MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-03-21 for SILICONE MEMBRANE OXYGENATOR I-25800-2A 61399402621 manufactured by Medtronic Perfusion Systems.
[720049]
Medtronic received information that this silicone oxygenerator exhibited a liquid to gas leak while priming the unit. The perfusionist suspected a membrane leak. The product was changed out prior to use, with no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[7866708]
Analysis: visual examination of the returned device noted no signs of physical damage. Examination did identify the presence of moisture in the gas port. Pressure tests were then performed on the device, which resulted in additional fluid exiting the gas port. The device was then dissected, which confirmed the presence of moisture inside the envelope near the center roll. Attempts were then made to identify and isolate the leak path. The leak path, however, could not be identified, and the root cause of moisture entering the envelope could not be determined. Medtronic has received similar reports of membrane leaks with this model silicone oxygenator. Investigation of those reports has identified possible causes for the leaks, which are currently being addressed by manufacturing. Specifically, steps have been taken in manufacturing to reduce assembly variability, and packaging improvements are being assessed in efforts to reduce damage that may occur during shipment. Medtronic continues to monitor field performance to detect similar events, should they occur. Conclusion: reduced device performance occurred and was related to the event. Clinical observation made while priming of the unit, prior to use, with no patient involvement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2007-00046 |
| MDR Report Key | 928584 |
| Report Source | 05,07 |
| Date Received | 2007-03-21 |
| Date of Report | 2007-02-22 |
| Report Date | 2007-02-22 |
| Date Reported to Mfgr | 2007-02-22 |
| Date Mfgr Received | 2007-02-22 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2007-10-18 |
| 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 | 2007-03-21 |
| Returned To Mfg | 2007-03-01 |
| Model Number | I-25800-2A |
| Catalog Number | 61399402621 |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2007-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 900689 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-21 |