MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-03-14 for SILICONE MEMBRANE OXYGENATOR I-3500-2A 61399402653 manufactured by Medtronic Perfusion Systems.
[683538]
Medtronic received info that this silicone membrane oxygenator demonstrated a leak from the sleeve of the oxygenator. This observation was made while priming the unit prior to bypass, with no impact to the pt.
Patient Sequence No: 1, Text Type: D, B5
[7862191]
Eval method: device history reviewed. Results: device history review found the product met specifications when released for distribution. Conclusion:exact cause of event cannot be determined as the product has not been returned for analysis. Analysis: to date, this product has not been returned to medtronic for analysis. Return of the device is anticipated. Without product return, analysis is limited to review of the device history records, which demonstrate that this device met mfg specifications when released for distribution. Conclusion: exact cause of the event cannot be determined at this time as the product has not been returned for analysis. When the product is returned, a follow up report will be submitted to fda upon completion of the analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2007-00043 |
| MDR Report Key | 907325 |
| Report Source | 05,07 |
| Date Received | 2007-03-14 |
| Date of Report | 2007-02-12 |
| Report Date | 2007-02-12 |
| Date Reported to Mfgr | 2007-02-12 |
| Date Mfgr Received | 2007-02-12 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2007-09-05 |
| 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 | 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 | 2007-03-14 |
| Model Number | I-3500-2A |
| Catalog Number | 61399402653 |
| Lot Number | 3835943 |
| ID Number | NA |
| Device Expiration Date | 2008-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 881820 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-14 |