MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-04 for BIOMEDICUS NONE * manufactured by Medtronic Bio-medicus, Inc..
[20840]
After one hour into open-heart surgery procedure, perfusionist noticed large bolus of air from venous reservoir to pump head. Tubing clamped off, air eliminated but when turning pump back on, it failed to start. Replaced with second pump.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35678 |
| MDR Report Key | 35678 |
| Date Received | 1996-08-15 |
| Date of Report | 1996-08-06 |
| Date of Event | 1996-08-05 |
| Date Facility Aware | 1996-08-05 |
| Report Date | 1996-08-06 |
| Date Added to Maude | 1996-08-22 |
| 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 | BIOMEDICUS |
| Generic Name | PUMP |
| Product Code | HQY |
| Date Received | 1996-09-04 |
| Model Number | NONE |
| Catalog Number | * |
| Lot Number | NONE |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 37106 |
| Manufacturer | MEDTRONIC BIO-MEDICUS, INC. |
| Manufacturer Address | 9600 WEST 76TH ST EDEN PRAIRIE MN 55344 US |
| Baseline Brand Name | RAY-BAN SUNGLASSES |
| Baseline Generic Name | SUNGLASSES |
| Baseline Model No | MULTIPLE |
| Baseline Catalog No | VARIOUS |
| Baseline ID | NONE |
| Baseline Device Family | SUNGLASSES |
| Baseline Shelf Life Contained | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1996-08-15 |