MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for HEARTMATE 3 SYSTEM CONTROLLER 106531US manufactured by Thoratec Corporation.
[187039767]
Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed based on the information recorded in the log file. The data log file was successfully retrieved from the returned system controller serial number (b)(4) and contained events recorded from (b)(6) 2019 where a backup battery fault alarm associated with a battery load test failure was recorded through the entire log file. The pump support was not affected and the system maintained the desired set speed. The system controller was functionally tested using the laboratory equipment and was found to function as intended. A full functional test was performed and the controller passed all test steps. The system controller operated for extended period of time while connected to a mock circulatory loop and the backup battery fault alarm was not able to be reproduced. During testing, multiple load tests were performed and the controller passed each time without issue. A specific root cause of the backup battery load test failure recorded in the log file was unable to be conclusively determined during this investigation. The backup battery fault alarm observed in the log file did not affect the controller's ability to support the pump at the set speed. Abbott is continuing to monitor this issue. No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10
[187039768]
It was reported that the patient experienced a backup battery fault alarm. Patient's backup battery was replaced, however the alarm returned so the patient's controller was exchanged with no issue. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01831 |
| MDR Report Key | 9908120 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. BOB FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528204 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 95488 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE 3 SYSTEM CONTROLLER |
| Generic Name | VENTRICULAR (ASSISST) BYPASS |
| Product Code | DSQ |
| Date Received | 2020-03-31 |
| Model Number | 106531US |
| Catalog Number | 106531US |
| Lot Number | 6968737 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | 6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |