MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for HEARTMATE 3 SYSTEM CONTROLLER 106531INT manufactured by Thoratec Corporation.
[186755379]
Manufacturer's investigation conclusion: the reported event of backup battery fault alarms on (b)(6) 2020 was not confirmed. The system controller (serial #: (b)(4)) was returned for analysis and a log file was submitted for review (91060814) as well as downloaded from the returned controller (92181036). A review of the submitted log files showed overlapping events spanning approximately 612 days (06jun2018? 18feb2020). The driveline was never connected to the controller. Backup battery fault alarms were never active on the reported event date of (b)(6) 2020; however, they were intermittently active prior to the event date. The root cause for the reported event was not conclusively determined through this analysis. Heartmate iii instructions for use section 7 entitled? Alarms and troubleshooting? And heartmate iii patient handbook section 5 entitled? Alarms and troubleshooting? Addresses how to properly interpret and troubleshoot all system alarms. The patient handbook cautions 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
[186755380]
It was reported that the system controller showed the "back up battery fault" alarm again. The backup battery had been replaced several times before. The clinician decided to replace the system controller.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01747 |
| MDR Report Key | 9903045 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2015-10-29 |
| 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 | 2020-02-17 |
| Model Number | 106531INT |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 |