BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 13125242 · Received December 31, 2021

    Report

    Report Number
    2916596-2021-07364
    Event Type
    Malfunction
    Date Received
    December 31, 2021
    Date of Event
    December 3, 2021
    Report Date
    March 2, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER¿S BATTERY GAUGE NOT MATCHING THE BATTERY LIGHTS ON EXTERNAL 14-VOLT BATTERIES WAS NOT CONFIRMED. THE PROVIDED LOG FILE AND A LOG FILE EXTRACTED FROM THE CONTROLLER DURING TESTING WERE REVIEWED, COLLECTIVELY CONTAINING DATA SPANNING APPROXIMATELY 1 DAY (02DEC2021 ¿ 03DEC2021 PER TIME STAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE, AND NO ATYPICAL EVENTS WERE OBSERVED. THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(6)) WAS FUNCTIONALLY TESTED AND WAS FOUND TO PERFORM AS INTENDED. THE CONTROLLER OPERATED ON CHARGED 14-VOLT BATTERIES FOR AN EXTENDED PERIOD AND ITS BATTERY GAUGE WAS CHECKED MULTIPLE TIMES THROUGHOUT TESTING. THE CONTROLLER¿S BATTERY GAUGE ALWAYS SHOWED FOUR FULL GREEN BARS WHILE CONNECTED TO THE CHARGED BATTERIES, MATCHING THE BATTERIES¿ GAUGES. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿) INSTRUCTS USERS ON HOW TO PROPERLY USE THE CONTROLLER¿S BATTERY GAUGE FUNCTION. THE BATTERY POWER GAUGE SHOWS THE APPROXIMATE CHARGE STATUS OF THE POWER SOURCE THAT IS CONNECTED TO THE SYSTEM CONTROLLER¿S WHITE AND BLACK POWER CABLES¿EITHER THE 14 VOLT LITHIUM-ION BATTERIES OR THE MOBILE POWER UNIT. THE HEARTMATE 3 PATIENT HANDBOOK SECTION TITLED "EMERGENCY CONTACT LIST") CAUTIONS 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.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT THE BATTERY GAUGE LIGHTS ON THE CONTROLLER WERE RUNNING DOWN TO TWO BARS WITHIN AN HOUR OR LESS OF BEING ON FULLY CHARGED EXTERNAL BATTERIES. THE BATTERY GAUGE ON THE BATTERIES REMAINED AT 4-5 BARS. THE EVENT LOG DISPLAYED MULTIPLE INTERMITTENT LOW FLOWS WHERE THE LOW FLOW ESTIMATOR DROPPED BELOW 2.0 LPM (WHICH IS BASELINE FOR THE PATIENT) BUT DID NOT DISPLAY ANY ALARMS OR UNUSUAL EVENTS IN REGARDS TO BATTERY USE. THE CONTROLLER WAS TETHERED TO THE MOBILE POWER UNIT FROM (B)(6) 2021 7:22 PM TO (B)(6) 2021 7:42 AM. THE PATIENT DID NOT EXPERIENCE ANY LOW VOLTAGE OR LOW POWER ALARMS. THE PATIENT WAS SWITCHED TO HER BACKUP CONTROLLER AND A REPLACEMENT CONTROLLER WITH LOW FLOW 2.0 SOFTWARE WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027497 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female