HEARTMATE 3 SYSTEM CONTROLLER 106531US

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number2916596-2020-01690
MDR Report Key9908355
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-07
Date Mfgr Received2020-03-19
Device Manufacturer Date2018-06-13
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BOB FRYC
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone7818528204
Manufacturer G1THORATEC CORPORATION
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 95488
Manufacturer CountryUS
Manufacturer Postal Code95488
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEARTMATE 3 SYSTEM CONTROLLER
Generic NameVENTRICULAR (ASSISST) BYPASS
Product CodeDSQ
Date Received2020-03-31
Returned To Mfg2020-02-20
Model Number106531US
Catalog Number106531US
Lot Number6545154
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTHORATEC CORPORATION
Manufacturer Address6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.