MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-23 for * manufactured by Medtronic Perfusion Systems.
[344857]
An ecmo membrane connected to a patient was noted to be leaking. The membrane was changed per protocol, and the patient continues to remain on ecmo. This particular membrane was removed from service, and will be returned to the vendor. However, this type of membrane does continue to be used at the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 578523 |
| MDR Report Key | 578523 |
| Date Received | 2005-02-23 |
| Date of Report | 2005-02-23 |
| Date of Event | 2005-02-15 |
| Report Date | 2005-02-23 |
| Date Reported to FDA | 2005-02-23 |
| Date Added to Maude | 2005-03-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | ECMO MEMBRANE |
| Product Code | BYS |
| Date Received | 2005-02-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 568373 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-23 |