MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-06 for TCM II Y CIRCUIT 14191010 manufactured by Sarns 3m Health Care, Inc..
[5298]
During cardiopulmonary bypass, following removal of the aortic clamp, the h20 temperature of the systemic heater/cooler was allowed to cool rather than warm. The water temperature dropped from 40 degrees c to 26 degrees c. This caused a drip in blood temperature from 36 degress c to 28 degrees c. A different heater/cooler was brought in to complete the procedure. No adverse effect on pt. A combination of valves and tees recommended by the mfr may contribute to operator error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000016 |
| MDR Report Key | 10377 |
| Date Received | 1993-12-06 |
| Date of Report | 1993-11-12 |
| Date of Event | 1993-09-16 |
| Date Added to Maude | 1993-12-07 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCM II Y CIRCUIT |
| Generic Name | 1/2" 2-WAY BALL VALVE |
| Product Code | MJJ |
| Date Received | 1993-12-06 |
| Model Number | 14191010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10377 |
| Manufacturer | SARNS 3M HEALTH CARE, INC. |
| Manufacturer Address | ANN ARBOR MI 48103 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1993-12-06 |