MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-07-25 for SILICONE MEMBRANE OXYGENATOR I-2500-2A 61399402621 manufactured by Medtronic Perfusion Systems.
[18216157]
Evaluation: device history review found the product met specifications when released for distribution. Analysis: reason for return was confirmed. Visual inspection shows blood stains on outer wrap and on foam below. This most likely occurred due to the device returned in a bloody plastic bag. Unit was cleaned and run at 4. 5 l/min with 10 psi back pressure. Slight moisture was observed exiting the gas port during this 30 minute run. Unit was then dissected which confirms some moisture inside the envelope near the start roll. Unit was dried and vacuum tested. Vacuum test shows 1 small leak, approx. 4 feet from start roll, near the side seam. Microscope inspection shows a small cut across fabric. Review of the device history record shows that this device met manufacturing specifications when released for distribution. Medtronic has received similar reports of leaking silicone membrane oxygenators. Investigation of the membrane leak complaints shows no definite trend as to the leak path in the silicone membrane envelope. Leaks have been confirmed in the middle and on the edge of the envelope, and have varied through the length of the envelope. Investigation into the manufacturing process at this time suggests that either excessive handling due to a tight silicone sleeve, excessive handling during repairs following perfusion test stand rejections, or membrane strength variability due to fabric depth within the silicone may contribute to the reported clinical events. Actions have been taken to mitigate recurrence of the issue. This product was manufactured prior to implementation of these enhancements. Conclusion: reduced performance of the device occurred and is related to the event. Failure identified during prime with no patient involvement. Medtronic continues to monitor field performance to detect similar events.
Patient Sequence No: 1, Text Type: N, H10
[18329213]
Medtronic received information that this silicone oxygenator leaked while blood priming the unit. The unit was changed out and the case was completed without patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2007-00082 |
| MDR Report Key | 886883 |
| Report Source | 05,07 |
| Date Received | 2007-07-25 |
| Date of Report | 2007-06-27 |
| Date of Event | 2007-06-26 |
| Date Facility Aware | 2007-06-26 |
| Report Date | 2007-06-27 |
| Date Reported to Mfgr | 2007-06-27 |
| Date Mfgr Received | 2007-06-27 |
| Device Manufacturer Date | 2005-09-30 |
| Date Added to Maude | 2008-02-06 |
| 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 DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919558 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| 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 |
| Product Code | BYS |
| Date Received | 2007-07-25 |
| Returned To Mfg | 2007-07-06 |
| Model Number | I-2500-2A |
| Catalog Number | 61399402621 |
| Lot Number | 0509004582 |
| ID Number | NA |
| Device Expiration Date | 2007-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 959855 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-25 |