MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-02-05 for FRESENIUS HOME HEMO WITH PRIME BAG 03-2962-3 manufactured by Fresenius Medical Care North America.
[37566734]
(b)(4). The complainant indicated that the device was not available for evaluation. Plant investigation is in process. A supplemental mdr will be submitted upon the completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[37566735]
A user facility reported that approximately 2. 5 hours into the home hemodialysis treatment, the patient became aware of a blood leak. The patient called the home hemodialysis nurse (rn) to inform her of the incident, and subsequently reported feeling dizzy and having low blood pressure. The nurse alerted the authorities for a medical emergency, and the patient was transported to the hospital via ambulance for an assessment and blood work. The patient was discharged home. No medical intervention was reported. The estimated blood loss (ebl) was not known. Follow-up information was provided by the at-home nurse who revealed that the bloodline was brought into the clinic on (b)(6) 2016 where it was inspected by both the patient and staff. Reportedly, the venous tubing was misaligned when attached to the dialyzer. No damage to the tubing was visible. The blood leak occurred at the dialyzer and venous connection site. Additionally, the patient was previously instructed on the proper use of moisture sensors, but no sensors were placed on the floor during the treatment. Following this event, the patient was scheduled to return to the clinic for a one week review of at home safety protocols. Further information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[39544084]
The complaint device was not returned and no companion sample was available to the manufacturer for physical evaluation. Additionally, no alternate samples were available for analysis as all related lots have been sold and distributed. A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date. This review included the lot numbers for all bloodline tubing sets shipped to this account within the selected time frame. A records review was performed on each identified lot. An investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the batch record review confirmed the labeling, material, and process controls were within specification.
Patient Sequence No: 1, Text Type: N, H10
[39544105]
Follow-up information was provided by the home hemodialysis mrn. The patient's estimated blood loss was not known. However, on (b)(6) 2016, the patient's hemoglobin was 106. A few days after the event, on (b)(6) 2016, the patient's hemoglobin was once again tested and was found to be down to 88. The patient spent the night in the hospital's emergency department, had blood work completed, and was discharged the following day ((b)(6) 2016). The patient's current condition was reported as being fine. The patient has completely recovered and is doing well.
Patient Sequence No: 1, Text Type: D, B5
[44485314]
Manufacturing evaluation: the complaint device was not returned and no companion sample was available to the manufacturer for physical evaluation. Additionally, no alternate samples were available for analysis as all related lots have been sold and distributed. A records review was performed on the reported lot. An investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the batch record review confirmed the labeling, material, and process controls were within specification. Clinical investigation: the patient medical records were provided by the facility on april 6, 2016. A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event. On (b)(6) 2016, the patient called the home health registered nurse (rn) approximately 2 hours into the hemodialysis treatment after observing a moderately sized? Puddle of blood? Dripping to the floor from the venous end of the dialyzer. Reportedly, the patient failed to place a leak alert sensor below the dialyzer as instructed to do during the home health training. Emergency services were contacted and the patient was transported to the hospital for assessment. The patient was discharged the following day ((b)(6) 2016), and then scheduled to return to the clinic for a one week review of safety protocols at home. The patient initially indicated that the venous bloodline tubing was defective and cracked which resulted in the blood leak. However, upon examination of the device at the home health clinic, the home health rn determined that the venous bloodline was not threaded (connected) properly or correctly secured to the revaclear dialyzer at the venous end. No crack was visible in the tubing; the blood appeared to have leaked around the dialyzer and venous connection site. Additionally, the patient admitted not being able to return the blood within the circuit. Furthermore, the patient failed to use moisture sensors on the floor, beneath the dialyzer, as she had been previously instructed to do during home hd training. The patient was scheduled to return to the clinic for a one week review of home hemodialysis safety protocols. Medical records confirm that no device malfunction occurred. Based on the documentation provided within the patient? S medical records, the adverse event likely occurred as a result of user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030665-2016-00050 |
| MDR Report Key | 5413566 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-02-05 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-01-08 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2015-08-19 |
| Date Added to Maude | 2016-02-05 |
| 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 | TANYA TAFT |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA, TAMAULIPAS CP 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS HOME HEMO WITH PRIME BAG |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-02-05 |
| Catalog Number | 03-2962-3 |
| Lot Number | 15KR01074 |
| ID Number | 00840861100330 |
| Device Expiration Date | 2018-08-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA, TAMAULIPAS CP 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-02-05 |