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 health professional report with the FDA on 2020-03-31 for HEARTMATE 3 SYSTEM CONTROLLER 106531US manufactured by Thoratec Corporation.

Event Text Entries

[187039767] Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed based on the information recorded in the log file. The data log file was successfully retrieved from the returned system controller serial number (b)(4) and contained events recorded from (b)(6) 2019 where a backup battery fault alarm associated with a battery load test failure was recorded through the entire log file. The pump support was not affected and the system maintained the desired set speed. The system controller was functionally tested using the laboratory equipment and was found to function as intended. A full functional test was performed and the controller passed all test steps. The system controller operated for extended period of time while connected to a mock circulatory loop and the backup battery fault alarm was not able to be reproduced. During testing, multiple load tests were performed and the controller passed each time without issue. A specific root cause of the backup battery load test failure recorded in the log file was unable to be conclusively determined during this investigation. The backup battery fault alarm observed in the log file did not affect the controller's ability to support the pump at the set speed. Abbott is continuing to monitor this issue. No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10


[187039768] It was reported that the patient experienced a backup battery fault alarm. Patient's backup battery was replaced, however the alarm returned so the patient's controller was exchanged with no issue. No further information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916596-2020-01831
MDR Report Key9908120
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-12-01
Date Mfgr Received2020-03-26
Device Manufacturer Date2019-03-20
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
Model Number106531US
Catalog Number106531US
Lot Number6968737
OperatorLAY USER/PATIENT
Device Availability*
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

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