MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-05-17 for SILICONE MEMBRANE OXYGENATOR I-4500-2A 61399402655 manufactured by Medtronic Perfusion Systems.
[617745]
Medtronic received info that this oxygenator exhibited a leak at the gas outlet port. This observation was made after 2 hours of use. The leak continued for 30 hours into the ecmo case. In addition, the customer reported seeing tiny air bubbles at the top of the oxygenator and in the arterial side of the circuit. It is not known at this time if the device was changed out. To date, no adverse pt effects have been reported.
Patient Sequence No: 1, Text Type: D, B5
[7956981]
Analysis: to date, this product has not been returned for analysis. Return of the product is anticipated. Without product return, analysis at this time is limited to review of the device history record, which shows that this product met manufacturing 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. Return is anticipated. There have been no reported adverse pt effects.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2007-00065 |
| MDR Report Key | 852486 |
| Report Source | 05,07 |
| Date Received | 2007-05-17 |
| Date of Report | 2007-04-18 |
| Date of Event | 2007-04-08 |
| Date Facility Aware | 2007-04-08 |
| Report Date | 2007-04-18 |
| Date Reported to Mfgr | 2007-04-18 |
| Date Mfgr Received | 2007-04-18 |
| Date Added to Maude | 2007-05-24 |
| 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 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 |
| Product Code | BYS |
| Date Received | 2007-05-17 |
| Model Number | I-4500-2A |
| Catalog Number | 61399402655 |
| Lot Number | IH30796 |
| ID Number | NA |
| Device Expiration Date | 2008-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 840218 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-17 |