MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for PROTOCO2L INSUFFLATION SYSTEM 6400 manufactured by E-z-em Inc.
[34244160]
The protoco2l insufflator is used for insufflation of the colon for ct colonoscopy (virtual) examination. No malfunction of the protoco2l insufflator was reported by the user facility. The insufflation pressure was reported to be 18 mmhg. 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. For the patient in this report, the ct colonoscopy images revealed a small amount of free air in the left abdomen and inflammation around the sigmoid colon. The doctor's opinion was that the patient may have had inflammation in the colon due to steroid administration and the fact that the device functioned correctly. The risk of perforation was considered attributable to the patient's background (pre-existing condition). Company comment: a female patient in her 60s with colon cancer underwent a preoperative ct colonography and the protoco2l insufflator was used for insufflation of the colon. The patient had rheumatoid arthritis and was on steroid therapy. No abnormal symptoms were observed during the procedure; once the patient returned to her room she experienced abdominal pain, and the ct images revealed a small amount of free air in the left abdomen and inflammation around the sigmoid colon; the patient was diagnosed with perforated sigmoid diverticulitis. The reporting physician suggested that inflammation had already been present before ct colonography due to steroid administration, since it was more intense than usually seen immediately after perforation. The patient was treated with antibiotics and gamma-globulins and recovered on an unknown date. The pressure of the device was reported to be 18mmhg, therefore well below the safety feature of pressure relief valve. In fact, 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. No malfunction of the device was reported. Bracco agrees with the reporter's opinion that an accidental perforation occurred in an existing area of inflammation due to steroid therapy, therefore it was rather due to the patient's pre-existing conditions. Of note, the use of protoco2l insufflator is contraindicated when rectal conditions such as inflammatory or neoplastic diseases are suspected.
Patient Sequence No: 1, Text Type: N, H10
[34244161]
On (b)(6) 2015, (b)(6) was notified by eidia co. Ltd. , a (b)(6), of an event of perforation after a ct colonography where insufflation was accomplished using a protoco2l insufflation system. Protoco2l insufflation system serial number (b)(4) was used with protoco2l vc administration set (tubing set), catalog number 6470. A physician in (b)(6) at (name withheld for privacy) hospital reported: a female patient in her 60s with rheumatoid arthritis was admitted to hospital to undergo preoperative ct colonography in (b)(6) 2014. The patient was on steroid therapy. Bowel preparation for the colonography was low residue diet meals and magcorol. The colon insufflation pressure was 18 mmhg. Although no abnormal symptoms were observed during the ct colonography, the patient complained of abdominal pain after she returned to her room. The ct images revealed a small amount of free air in the left abdomen and inflammation around the sigmoid colon. The patient was diagnosed with perforated sigmoid diverticulitis. However, the inflammation was more intense than usually seen immediately after perforation, suggesting that the inflammation due to steroid administration had been present since before ct colonography. The steroid therapy was withdrawn and replaced with 7 days of antibiotic meropenem and 3 days of gamma-globulin administration. After recovery, she underwent the rest of the tests for preoperative colon cancer assessment to fulfill the original purpose of her hospital stay and then was discharged from hospital (24 days after admission, 19 days after the day of perforation confirmed). No particular event has been reported from the patient follow up. No malfunction of the device was reported. The physician reported that the device was still being used at the hospital and there were no problems with any other procedures while using the device. The doctor's opinion was that the patient may have had inflammation in the colon due to steroid administration and the fact that the device functioned correctly, the risk of perforation, etc. Was considered attributable to the patient's background. The case was judged to be due to an accidental perforation in the existing area of inflammation despite the careful testing procedures, rather than device malfunction.
Patient Sequence No: 1, Text Type: D, B5
[40762380]
The protoco2l insufflator is used for insufflation of the colon for ct colonoscopy (virtual) examination. No malfunction of the protoco2l insufflator was reported by the user facility. The insufflation pressure was reported to be 18 mmhg. 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. For the patient in this report, the ct colonoscopy images revealed a small amount of free air in the left abdomen and inflammation around the sigmoid colon. The doctor's opinion was that the patient may have had inflammation in the colon due to steroid administration and the fact that the device functioned correctly. The risk of perforation was considered attributable to the patient's background (pre-existing condition). (b)(4) 2015: bracco' quality group conducted an investigation and provided a summary of the investigation results. A device history review (dhr) was performed because the machine was not inspected by the service department. The dhr summary results were: the quality assurance engineer (qae) performed a dhr of the protoco2l insufflator (serial number (b)(4)). It was manufactured in august of 2011. The unit went through final quality control testing on 01-sep-2011. Nothing out of the ordinary was noted in the test pack of the insufflator. During a review of the return material authorization (rma) log, it was noted that the unit has never been returned for service or scheduled maintenance. No corrective and preventive action was taken. Conclusion: based on the dhr review, the qae can only conclude that the unit was manufactured to specifications and satisfied all the tests prior to shipment. Company comment: a female patient in her 60s with colon cancer underwent a preoperative ct colonography and the protoco2l insufflator was used for insufflation of the colon. The patient had rheumatoid arthritis and was on steroid therapy. No abnormal symptoms were observed during the procedure; once the patient returned to her room she experienced abdominal pain, and the ct images revealed a small amount of free air in the left abdomen and inflammation around the sigmoid colon; the patient was diagnosed with perforated sigmoid diverticulitis. The reporting physician suggested that inflammation had already been present before ct colonography due to steroid administration, since it was more intense than usually seen immediately after perforation. The patient was treated with antibiotics and gamma-globulins and recovered on an unknown date. The pressure of the device was reported to be 18mmhg, therefore well below the safety feature of pressure relief valve. In fact, 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. No malfunction of the device was reported. Bracco agrees with the reporter's opinion that an accidental perforation occurred in an existing area of inflammation due to steroid therapy, therefore it was rather due to the patient's pre-existing conditions. Of note, the use of protoco2l insufflator is contraindicated when rectal conditions such as inflammatory or neoplastic diseases are suspected.
Patient Sequence No: 1, Text Type: N, H10
[40762381]
On (b)(4) 2015, bracco drug safety was notified by (b)(4), a bracco partner in (b)(4), of an event of perforation after a ct colonography where insufflation was accomplished using a protoco2l insufflation system. Protoco2l insufflation system serial number (b)(4) was used with protoco2l vc administration set (tubing set), catalog number 6470. A physician in (b)(6) at (name withheld for privacy) hospital reported: a female patient in her 60s with rheumatoid arthritis was admitted to hospital to undergo preoperative ct colonography in (b)(6) 2014. The patient was on steroid therapy. Bowel preparation for the colonography was low residue diet meals and magcorol. The colon insufflation pressure was 18 mmhg. Although no abnormal symptoms were observed during the ct colonography, the patient complained of abdominal pain after she returned to her room. The ct images revealed a small amount of free air in the left abdomen and inflammation around the sigmoid colon. The patient was diagnosed with perforated sigmoid diverticulitis. However, the inflammation was more intense than usually seen immediately after perforation, suggesting that the inflammation due to steroid administration had been present since before ct colonography. The steroid therapy was withdrawn and replaced with 7 days of antibiotic meropenem and 3 days of gamma-globulin administration. After recovery, she underwent the rest of the tests for preoperative colon cancer assessment to fulfill the original purpose of her hospital stay and then was discharged from hospital (24 days after admission, 19 days after the day of perforation confirmed). No particular event has been reported from the patient follow up. No malfunction of the device was reported. The physician reported that the device was still being used at the hospital and there were no problems with any other procedures while using the device. The doctor's opinion was that the patient may have had inflammation in the colon due to steroid administration and the fact that the device functioned correctly, the risk of perforation, etc. Was considered attributable to the patient's background. The case was judged to be due to an accidental perforation in the existing area of inflammation despite the careful testing procedures, rather than device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411512-2015-00003 |
| MDR Report Key | 5321044 |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-03 |
| Date Mfgr Received | 2015-12-18 |
| Date Added to Maude | 2015-12-22 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICE MARCHILDON |
| Manufacturer Street | 525 BROADHOLLOW ROAD |
| Manufacturer City | MELVILLE 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTOCO2L INSUFFLATION SYSTEM |
| Generic Name | INSUFFLATOR, AUTOMATIC CARBON DIOXIDE |
| Product Code | FCX |
| Date Received | 2015-12-22 |
| Catalog Number | 6400 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM INC |
| Manufacturer Address | 532 BROADHOLLOW ROAD MELVILLE 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-12-22 |