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

[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


MAUDE Entry Details

Report Number2916596-2020-01840
MDR Report Key9908184
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-10
Date Mfgr Received2020-03-30
Device Manufacturer Date2018-03-09
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 Number6443947
OperatorHEALTH PROFESSIONAL
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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