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.
[187040173]
Manufacturer's investigation conclusion: the report of backup battery fault alarms was confirmed through the analysis of submitted data log files. The first three log files were retrieved from system controller sn (b)(6) and captured events in the date ranges of (b)(6) 2019, and (b)(6) 2019, per the timestamps. These logs captured multiple transient backup battery fault alarms as a result of active backup battery circuit faults. All of these events were triggered when the white power cable was captured as disconnected from external power and resolved when it was reconnected to external power. None of these events affected the controller's ability to support the pump at the set speed and no backup battery fault alarms were captured when the white power cable was captured as disconnected. The fourth submitted log file was retrieved from system controller sn (b)(4). Per the log file the controller was connected to an lvad on (b)(6) 2019 and supported the pump at the set speed without any atypical alarms or events being captured throughout the remainder of the log file. The log file was consistent with this controller being a replacement or back-up controller. The system controller used during the reported events was not returned for analysis. An attempt to obtain the product was unsuccessful. As a result, the root cause of the events captured in the submitted data log files could not be conclusively determined. However, based on the captured sequence of events and previous complaint experience, the events appear consistent with a possible connection issue between the system controller and its internal backup battery. Although the root cause of the backup battery fault alarms could not be conclusively determined, similar reports of backup battery fault alarms with unknown causes have been documented and corrective action (capa) has been initiated to investigate the issue. Reports of similar events will continue to be tracked and monitored. Heartmate 3 patient handbook section 5-"alarms and troubleshooting? And heartmate 3 instructions for use section 7-? Alarms and troubleshooting? Address all alarm conditions, including backup battery fault alarms, and the proper actions to take if the alarms cannot be resolved. Heartmate 3 instructions for use and heartmate 3 patient handbook both caution the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment. No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10
[187040174]
It was reported that the patient's system controller was exchanged due to backup battery fault alarms. The alarms resolved after system controller exchange.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01753 |
| MDR Report Key | 9902990 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-13 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2017-11-08 |
| 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 | 6437889 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |