MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-02 for CUSTOM PACK * manufactured by Avecor.
[16763220]
Level 2 code called at 11:15 pm (no chest compressions). Rupture in bladder noted. Back on ecmo at 11:41 pm. 8-10ccs of blood loss noted. 30ccs of rbcs subsequently given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 83317 |
| MDR Report Key | 83317 |
| Date Received | 1996-07-02 |
| Date of Report | 1996-04-02 |
| Date of Event | 1996-03-22 |
| Date Facility Aware | 1996-03-22 |
| Report Date | 1996-04-02 |
| Date Reported to Mfgr | 1996-04-02 |
| Date Added to Maude | 1997-04-15 |
| 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 |
| 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 | CUSTOM PACK |
| Generic Name | ECMO BLADDER |
| Product Code | BYS |
| Date Received | 1996-07-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CP95K16Q |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 82654 |
| Manufacturer | AVECOR |
| Manufacturer Address | 13010 COUNTY RD. 6 PLYMOUTH MN 554413828 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1996-07-02 |