MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-10-18 for SILICONE MEMBRANE OXYGENATOR I-2500-2A 61399402621 manufactured by Medtronic Perfusion Systems.
[683944]
Information received indicates that approximately one minute after placing a child on ecmo support, the oxygenator leaked. Location of the leak is not reported. The unit was changed out with no reported effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[7862703]
Analysis: the product was discarded by the hospital and will not be returned for analysis. Analysis is limited to a review of the device history record which showed the device met requirements for distribution. Conclusion: without the return of the product, the cause of the event cannot be determined. There was no reported consequence to the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2006-00095 |
| MDR Report Key | 908943 |
| Report Source | 05,07 |
| Date Received | 2006-10-18 |
| Date of Report | 2006-09-22 |
| Report Date | 2006-09-22 |
| Date Reported to Mfgr | 2006-09-22 |
| Date Mfgr Received | 2006-09-22 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2007-09-10 |
| 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 | LAURALIE MILLIKAN |
| Manufacturer Street | 7611 NORTHLAND DR. |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919124 |
| 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 | 2006-10-18 |
| 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 | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 883250 |
| 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 | 2006-10-18 |