MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2015-08-26 for PROTOCO2L INSUFFLATION SYSTEM 6400 manufactured by E-z-em Inc..
[24138625]
No malfunction of the device was reported. It worked normally and there were no issues during the procedure. The patient was seen by a surgeon and required surgical intervention and drainage six days after the procedure. Bracco has requested return of the protoco2l insufflator and plans to conduct an investigation. Additional information is required. Company comment: a (b)(6) female patient underwent a ct colonography due to an unknown reason and the protoco2l insufflator was used for insufflation of the colon. The next day she experienced slight hypogastric pain. Five days post procedure she was seen by her gynecologist due to possible pelvic infection and was hospitalized. White blood cells was 5900 mm3, increasing to 11400 mm3 with c-reactive protein of 12. 3 mg/dl. The patient was diagnosed with endoceliac abscess acute generalized peritonitis considered as a result of bowel perforation. Treatment included hartmann operation and drainage. The reporting physician noted he did not know the cause of events and that the device was working normally without any failure or issues during the procedure. The pressure of the device was reported to be 16mmhg. Additionally, the protoco2l has two pressure relief valves as safety features. A 50 mmhg electrically gated pressure relief valve will open if the pressure of 50 mmhg is sustained for five seconds and an audible alarm sounds. A fixed mechanical pressure relief valve will open at 75 mmhg. There was no report of an audible alarm sounding during this procedure. It was reported that the patient experienced a perforation six days post procedure and required surgical intervention. Based on the information provided, as it occurred and if were to recur, this occurrence is assessed as reportable as a mdr because it meets the criteria for reporting. Additional information is needed to determine cause of the perforation such as the pathology of the resected bowel. Hartmann's procedure is a common operation for management of malignant obstruction of the distal colon. The pressure reading (16 mmhg) of the insufflator during the procedure is well below the safety feature of pressure relief valve (50 mmhg). Also, use of the insufflator when inflammatory or neoplastic disease is suspected is contraindicated.
Patient Sequence No: 1, Text Type: N, H10
[24138626]
On 06-aug-2015 (b)(4), a bracco distributor in (b)(4) received adverse event information from a physician ((b)(6)) and forwarded the report to bracco on 13-aug-2015. The healthcare professional ((b)(6)) reported: on (b)(6) 2015, a (b)(6) female patient underwent a ct colonography due to an unknown reason. A protoco2l insufflation system, serial number (b)(4), was used for insufflation of the colon. Tubing set protoco2l vc administration set, catalog number 6470 was used with the protoco2l insufflation system. The patient's medical history included hyperlipidemia and a prior ct colonography performed three years ago. Concomitant medication use was reported as unknown. During pre-treatment of "washing the intestine," the patient experienced retching and emesis several times. Pre-treatment included administration of gastrografin (meglumine amidotrizoate; sodium amidotrizoate) and moviprep (ascorbic acid; macrogol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate) plus water as well as 10 mg of the anticonvulsant "cesden. " all symptoms resolved after pre-treatment was completed. On (b)(6) -2015, the ct colonography was performed. It was reported that the patient's body position was changed from an abdominal to supine position. The procedure was completed without incident and no discomfort was reported by the patient. The protoco2l insufflation system pressure reading was 16 mmhg and the total volume of co2 dispensed was 2800 ml. In the evening of (b)(6) 2015, following the procedure, the patient felt a slight feeling of fullness. The next day, she experienced slight hypogastric pain. Five days post testing, the patient was seen by her gynecologist and due to the possibility of pelvic infection, was admitted to the hospital six days post procedure. Body temperature was noted to be 37. 8 celsius (date unknown) and reported lab values included: white blood cell count (wbc) 5900 mm3 the testing, increasing to 11400 mm3 six days post testing and c-reactive protein (crp)12. 3 mg/dl (exact lab dates not provided). The reporting physician diagnosed the patient with "endoceliac abscess acute generalized peritonitis" considered to be a result of the perforation. Treatment included the hartmann operation and drainage. The reporting physician stated that he does not know the cause of the adverse events; that the device was working normally without any failure or issues during procedures. At the time of this report, the patient had not yet recovered. Additional information is required.
Patient Sequence No: 1, Text Type: D, B5
[34366461]
No malfunction of the device was reported. It worked normally and there were no issues during the procedure. The patient was seen by a surgeon and required surgical intervention and drainage six days after the procedure. Bracco has requested return of the protoco2l insufflator and plans to conduct an investigation. Additional information is required. 27-aug-2015 follow-up: the investigation report from the supplier became available: the unit is not expected to be returned to the us since it was reported that no malfunction was involved. The report covered only a device history review (dhr) since the machine had not been inspected by the supplier's service department. The quality assurance engineer (qae) performed a dhr of the protoco2l insufflator (sn#(b)(4)). It was manufactured with shop order #(b)(4) in june of 2011. The unit went through (b)(4) (bracco's contract manufacturer) final quality control testing on july 8, 2011. Nothing out of the ordinary was noted in the test pack of the insufflator. During a review of the maintenance record log, it was noted that the unit had never been returned for service or scheduled maintenance. Based on the device history record ( dhr) review, the qae concluded that the unit was manufactured to specifications and satisfied all the tests prior to shipment. Company comment: a (b)(6) female underwent a ct colonography due to an unknown reason and the protoco2l insufflator was used for insufflation of the colon. The next day she experienced slight hypogastric pain. Five days post procedure she was hospitalized due to possible pelvic infection. White blood cells was 5900 mm3, increasing to 11400 mm3 with c-reactive protein of 12. 3 mg/dl. She was diagnosed with endoceliac abscess acute generalized peritonitis considered as a result of bowel perforation. Treatment included hartmann operation and drainage. Patient recovered 3 months later. The reporting physician noted he did not know the cause of events and that the device was working normally without any failure or issues during the procedure. The pressure of the device was reported to be 16mmhg. Additionally, the protoco2l has two pressure relief valves as safety features. A 50 mmhg electrically gated pressure relief valve will open if the pressure of 50 mmhg is sustained for five seconds and an audible alarm sounds. A fixed mechanical pressure relief valve will open at 75 mmhg. There was no report of an audible alarm sounding during this procedure. The patient experienced a perforation six days post procedure and required surgical intervention. As the event occurred and if it were to recur, this occurrence is assessed as reportable as a mdr because it meets the criteria for reporting. Pathology of resected bowel was not available. (b)(6) procedure is a common operation for management of malignant obstruction of the distal colon. The pressure reading (16 mmhg) of the insufflator during the procedure is well below the safety feature of pressure relief valve (50 mmhg). Also, use of the insufflator in when inflammatory or neoplastic disease is suspected is contraindicated. Investigation by the device supplier noted that the device will not be returned since there was no malfunction. A device history review did not reveal any defects or history of any returned device for service.
Patient Sequence No: 1, Text Type: N, H10
[34366462]
On (b)(6) 2015 (b)(6) distributor in (b)(6) received adverse event information from a physician (digestive organs surgeon) and forwarded the report to bracco on 13-aug-2015. The healthcare professional (digestive organs surgeon) reported: on (b)(6) 2015, a (b)(6) female patient underwent a ct colonography due to an unknown reason. A protoco2l insufflation system, serial number (b)(4), was used for insufflation of the colon. Tubing set protoco2l vc administration set, catalog number 6470 was used with the protoco2l insufflation system. The patient's medical history included hyperlipidemia and a prior ct colonography performed three years ago. Concomitant medication use was reported as unknown. During pre-treatment of "washing the intestine," the patient experienced retching and emesis several times. Pre-treatment included administration of gastrografin (meglumine amidotrizoate; sodium amidotrizoate) and moviprep (ascorbic acid; macrogol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate) plus water as well as 10 mg of the anticonvulsant "cesden. " all symptoms resolved after pre-treatment was completed. On (b)(6) 2015, the ct colonography was performed. It was reported that the patient's body position was changed from an abdominal to supine position. The procedure was completed without incident and no discomfort was reported by the patient. The protoco2l insufflation system pressure reading was 16 mmhg and the total volume of co2 dispensed was 2800 ml. In the evening of (b)(6) 2015, following the procedure, the patient felt a slight feeling of fullness. The next day, she experienced slight hypogastric pain. Five days post testing, the patient was seen by her gynecologist and due to the possiblity of pelvic infection, was admitted to the hospital six days post procedure. Body temperature was noted to be 37. 8 celsius (date unknown) and reported lab values included: white blood cell count (wbc) 5900 mm3. The testing, increasing to 11400 mm3 six days post testing and c-reactive protein (crp)12. 3 mg/dl (exact lab dates not provided). The reporting physician diagnosed the patient with "endoceliac abscess acute generalized peritonitis" considered to be a result of the perforation. Treatment included the hartmann operation and drainage. The reporting physician stated that he does not know the cause of the adverse events; that the device was working normally without any failure or issues during procedures. At the time of this report, the patient had not yet recovered. Additional information is required. 24-nov-2015: follow up information was received by the reporter: surgery to reverse the artificial anus (colostomy reversal surgery) was performed on an unspecified date in 2015. The patient recovered and left the hospital on (b)(6) 2015. The reporter stated there were "no concerns". No further patient information was provided by the reporter. This case is medically closed.
Patient Sequence No: 1, Text Type: D, B5
[34568119]
No malfunction of the device was reported. It worked normally and there were no issues during the procedure. The patient was seen by a surgeon and required surgical intervention and drainage six days after the procedure. (b)(4) has requested return of the protoco2l insufflator and plans to conduct an investigation. Additional information is required. On 27-aug-2015 follow-up: the investigation report from the supplier became available: the unit is not expected to be returned to the us since it was reported that no malfunction was involved. The report covered only a device history review (dhr) since the machine had not been inspected by the supplier's service department. The quality assurance engineer (qae) performed a dhr of the protoco2l insufflator (sn#(b)(4)). It was manufactured with shop order #(b)(4) in june of 2011. The unit went through (b)(4) final quality control testing on july 8, 2011. Nothing out of the ordinary was noted in the test pack of the insufflator. During a review of the maintenance record log, it was noted that the unit had never been returned for service or scheduled maintenance. Based on the device history record ( dhr) review, the qae concluded that the unit was manufactured to specifications and satisfied all the tests prior to shipment. Company comment: a (b)(6) female underwent a ct colonography due to an unknown reason and the protoco2l insufflator was used for insufflation of the colon. The next day she experienced slight hypogastric pain. Five days post procedure she was hospitalized due to possible pelvic infection. White blood cells was 5900 mm3, increasing to 11400 mm3 with c-reactive protein of 12. 3 mg/dl. She was diagnosed with endoceliac abscess acute generalized peritonitis considered as a result of bowel perforation. Treatment included hartmann operation and drainage. The reporting physician noted he did not know the cause of events and that the device was working normally without any failure or issues during the procedure. The pressure of the device was reported to be 16mmhg. Additionally, the protoco2l has two pressure relief valves as safety features. A 50 mmhg electrically gated pressure relief valve will open if the pressure of 50 mmhg is sustained for five seconds and an audible alarm sounds. A fixed mechanical pressure relief valve will open at 75 mmhg. There was no report of an audible alarm sounding during this procedure. The patient experienced a perforation six days post procedure and required surgical intervention. As the event occurred and if it were to recur, this occurrence is assessed as reportable as a mdr because it meets the criteria for reporting. Pathology of resected bowel was not available. Hartmann's procedure is a common operation for management of malignant obstruction of the distal colon. The pressure reading (16 mmhg) of the insufflator during the procedure is well below the safety feature of pressure relief valve (50 mmhg). Also, use of the insufflator in when inflammatory or neoplastic disease is suspected is contraindicated. Investigation by the device supplier noted that the device will not be returned since there was no malfunction. A device history review did not reveal any defects or history of any returned device for service.
Patient Sequence No: 1, Text Type: N, H10
[34568120]
(b)(4). The healthcare professional (digestive organs surgeon) reported: on (b)(6) 2015, a (b)(6) female patient underwent a ct colonography due to an unknown reason. A protoco2l insufflation system, serial number (b)(4), was used for insufflation of the colon. Tubing set protoco2l vc administration set, catalog number 6470 was used with the protoco2l insufflation system. The patient's medical history included hyperlipidemia and a prior ct colonography performed three years ago. Concomitant medication use was reported as unknown. During pre-treatment of "washing the intestine," the patient experienced retching and emesis several times. Pre-treatment included administration of gastrografin (meglumine amidotrizoate; sodium amidotrizoate) and moviprep (ascorbic acid; macrogol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate) plus water as well as 10 mg of the anticonvulsant "cesden. " all symptoms resolved after pre-treatment was completed. On (b)(6) 2015, the ct colonography was performed. It was reported that the patient's body position was changed from an abdominal to supine position. The procedure was completed without incident and no discomfort was reported by the patient. The protoco2l insufflation system pressure reading was 16 mmhg and the total volume of co2 dispensed was 2800 ml. In the evening of (b)(6) 2015, following the procedure, the patient felt a slight feeling of fullness. The next day, she experienced slight hypogastric pain. Five days post testing, the patient was seen by her gynecologist and due to the possibility of pelvic infection, was admitted to the hospital six days post procedure. Body temperature was noted to be 37. 8 celsius (date unknown) and reported lab values included: white blood cell count (wbc) 5900 mm? At the testing, increasing to 11400 mm? Six days post testing and c-reactive protein (crp)12. 3 mg/dl (exact lab dates not provided). The reporting physician diagnosed the patient with "endoceliac abscess acute generalized peritonitis" considered to be a result of the perforation. Treatment included the hartmann operation and drainage. The reporting physician stated that he does not know the cause of the adverse events; that the device was working normally without any failure or issues during procedures. At the time of this report, the patient had not yet recovered. Additional information is required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411512-2015-00002 |
| MDR Report Key | 5032492 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2015-08-26 |
| Date of Report | 2015-08-25 |
| Date of Event | 2015-05-14 |
| Date Mfgr Received | 2015-08-06 |
| Date Added to Maude | 2015-08-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICE MARCHILDON |
| Manufacturer Street | 532 BROADHOLLOW ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6095142284 |
| Manufacturer G1 | EZEM |
| Manufacturer Street | 532 BROADHOLLOW ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTOCO2L INSUFFLATION SYSTEM |
| Generic Name | INSUFFLATOR, AUTOMATIC CARBON DIOXIDE |
| Product Code | FCX |
| Date Received | 2015-08-26 |
| Catalog Number | 6400 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM INC. |
| Manufacturer Address | 532 BROADHOLLOW ROAD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-08-26 |