MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for HEARTMATE 3 SYSTEM CONTROLLER 106531US manufactured by Thoratec Corporation.
[187039224]
Manufacturer's investigation conclusion: the reported event of backup battery fault alarms was confirmed via the submitted and downloaded log files. The system controller (serial #: (b)(4)) was returned for analysis and a log file was submitted for review (b)(4) as well as downloaded from the returned controller for review (b)(4). A review of the log files showed overlapping events spanning approximately 3 days ((b)(6) 2020 per time stamp). Backup battery fault alarms were active due to a load test failure. The backup battery fault alarms were active between (b)(6) 2020 at 17:52:20 to (b)(6) 2020 at 13:15:01. The backup battery failed the load test due to the loaded voltage being under the acceptable threshold as compare to the unloaded voltage. When the load test first failed, the loaded voltage measured ~11. 4v and the unloaded voltage measured ~12. 3v. Pump operation was not affected. The system controller underwent preliminary and functional testing. The system controller was connected to the mock loop and was able to operate for an extended operation as intended. The reported backup battery fault alarms were not able to be reproduced during this investigation. The root cause for the reported event was not able to be conclusively determined through this analysis. No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10
[187039225]
It was reported that the patient had multiple internal battery faults. The battery was replaced several times and the battery faults still returned. It was suggested to replace the controller. The controller was exchanged and returned for evaluation. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01690 |
| MDR Report Key | 9908355 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2018-06-13 |
| 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 |
| Returned To Mfg | 2020-02-20 |
| Model Number | 106531US |
| Catalog Number | 106531US |
| Lot Number | 6545154 |
| Device Availability | R |
| 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 |