MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2007-04-27 for SILICONE MEMBRANE OXYGENATOR I-4500-2A 61399402655 manufactured by Medtronic Perfusion Systems.
[617352]
Medtronic rec'd info that this silicone oxygenator exhibited a leak at the gas port. This observation was made 10 hrs into the ecmo procedure. Three hrs after first observing the leak, the decision was made to change out the device. The device was changed out with no reported clinical affects to the pt. It was reported that the pt subsequently expired due to other clinical complications. The cause of death was not provided.
Patient Sequence No: 1, Text Type: D, B5
[7958498]
H3 analysis: visual analysis of the returned product shows no outward signs of damage to the outer wrap of the device. The unit was decontaminated and run with fluid at 6. 5 l/min with 5psi back pressure. Within 5 mins, a leak was observed exiting the gas port. The unit was then dissected which shows body fluid residue inside the envelope, approx 4 ft from the end roll, near the side seam. A patch was present near the leak path. The unit was then dried and vacuum tested. The test shows one leak path, approx 4 ft from the end roll, near the side seam. The leak occurred on the loop side up surface, approx 1/4 inch from where the envelope had been patched. A small cut in the membrane was observed at this location. It is possible that the patch had been placed in the incorrect location during mfg. Medtronic has rec'd similar reports of membrane leaks with this model silicone oxygenator. Investigation of those reports had identified possible causes for the leaks, which are currently being addressed by mfg. Specifically, steps were taken in september of 2006 to reduce assembly variability. This device was manufactured prior to implementation of these process improvements. Medtronic continues to monitor field performance to detect similar events, should they occur. Conclusion: reduced performance of the device occurred and was related to the event. Device changed out with no reported adverse pt effects.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2007-00062 |
| MDR Report Key | 845816 |
| Report Source | 01,05,07 |
| Date Received | 2007-04-27 |
| Date of Report | 2007-03-28 |
| Report Date | 2007-03-28 |
| Date Reported to Mfgr | 2007-03-28 |
| Date Mfgr Received | 2007-03-28 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2007-05-10 |
| 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 | CHAD HEDLUND |
| Manufacturer Street | 7611 NORTHLAND DR. |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919558 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR. |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE MEMBRANE OXYGENATOR |
| Generic Name | BYS |
| Product Code | BYS |
| Date Received | 2007-04-27 |
| Returned To Mfg | 2007-04-03 |
| Model Number | I-4500-2A |
| Catalog Number | 61399402655 |
| Lot Number | 4898305 |
| ID Number | NA |
| Device Expiration Date | 2008-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DAY |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 832917 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-27 |