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.
[187046869]
Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed via the log file downloaded from the returned controller (serial number: (b)(4)); however, the alarm was not reproduced during testing. The log file contained approximately 14 days of data ((b)(6) 2019? (b)(6) 2020 per the timestamp). The log file captured backup battery fault alarms due to a backup battery load test failure on (b)(6) 2020 from 17:19:59 until the last event in the log file (captured at 17:35:14). The backup battery failed the load test due to the loaded voltage being under the acceptable threshold compared to the unloaded voltage. It was reported that the alarm occurred while switching power sources from the power module to batteries; however, it was observed in the log file that the alarm occurred after the patient had been connected to 14v batteries for approximately 14 minutes. The log file also captured low voltage hazard and no external power alarms due to a temporary loss of power while connected to the mpu on (b)(6) 2019 from 11:14:31 to 11:16:17; this event is addressed via the mpu investigation. The system controller backup battery supplied power to the system without issue during the loss of external power. No other notable alarms were active in the log file. The pump maintained a speed above or equal to the low speed limit throughout the log file while the driveline was connected. The returned system controller passed functional testing and successfully operated in a mock circulatory loop for an extended period of time without any issues or atypical alarms produced. During testing, multiple load tests were performed and the controller passed each time without issue. The root cause of the reported event could not be conclusively determined through this analysis. Incidental findings: dim pump running leds, faded software and serial number labels. No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10
[187046870]
It was reported that patient experienced a backup battery fault alarm. The patient was given a new controller and the alarm resolved. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01840 |
| MDR Report Key | 9908184 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2018-03-09 |
| 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 | 6443947 |
| Operator | HEALTH PROFESSIONAL |
| 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 |