MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for HEMOTHERM 400CE 86022 manufactured by Cincinnati Sub-zero Products, Inc..
[185051075]
While on cardiopulmonary bypass (cpb), heater cooler alarmed and stopped functioning. The right hand side of heater cooler (heat side) showed ee instead of temperature, and water was not flowing. I attempted a reboot resulting in the same error message. Water lines were quickly changed to a different heater cooler.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882413 |
| MDR Report Key | 9882413 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-23 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOTHERM |
| Generic Name | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS |
| Product Code | DWC |
| Date Received | 2020-03-26 |
| Model Number | 400CE |
| Catalog Number | 86022 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CINCINNATI SUB-ZERO PRODUCTS, INC. |
| Manufacturer Address | 12011 MOSTELLER RD 3RD FLOOR BLUE ASH OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |