BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 14170251 · Received April 21, 2022

    Report

    Report Number
    2916596-2022-10218
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 11, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT WAS REQUESTED BUT NOT PROVIDED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED DAMAGE TO THE WHITE POWER CABLE WAS CONFIRMED WITH THE EVALUATION OF THE RETURNED SYSTEM CONTROLLER SERIAL NUMBER(B)(6) (BACKUP BATTERY SERIAL NUMBER (B)(6). THE COLLECTED LOG FILE CONTAINED 256 EVENTS OVER APPROXIMATELY 3 DAYS FROM 01APR2022 TO 04APR2022, PER THE TIME STAMP. THE CONTROLLER SUPPORTED THE PUMP ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILE WHEN THE DRIVELINE WAS CONNECTED. NO NOTABLE ALARMS WERE ACTIVE THROUGHOUT THE LOG FILE. VISUAL INSPECTION OF THE RETURNED SYSTEM CONTROLLER REVEALED A TEAR IN THE INSULATION OF THE WHITE POWER CABLE. ALTHOUGH THE ROOT CAUSE OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED, IT APPEARED TO BE A RESULT OF HANDLING. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED DURING ANALYSIS. THE CONFIRMED DAMAGE DID NOT AFFECT THE CONTROLLER'S ABILITY TO SUPPORT AN LVAD AS DESIGNED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE CONTROLLER WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. SYSTEM CONTROLLER SERIAL NUMBER (B)(6) WAS SHIPPED TO THE CUSTOMER ON 12JUL2016 ON CUSTOMER ORDER S180497. INCIDENTAL FINDINGS: GREEN FLUID UNDERNEATH THE OUTER JACKET AND EARLY CONDUCTOR BREAKDOWN. HEARTMATE 3 PATIENT HANDBOOK CAUTIONS THE USERS TO ¿CALL YOUR HOSPITAL CONTACT IF YOU THINK THAT, FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. YOUR HOSPITAL CONTACT CAN CHECK THE EQUIPMENT AND ORDER REPLACEMENTS, IF NEEDED. DO NOT TRY TO REPAIR ANYTHING YOURSELF.¿ UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ INFORMS THE USER: ¿DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, OR MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE¿. ALSO, IN THIS SECTION, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, ALL ALARM CONDITIONS ARE ADDRESSED. UNDER SECTION 6, ENTITLED ¿CARING FOR THE EQUIPMENT¿, ADDRESSES THE CLEANING AND CARING FOR THE EQUIPMENT THAT INCLUDE CAUTIONS REGARDING SUBMERSION OF THE DRIVELINE, MODULAR CONNECTOR, SYSTEM CONTROLLER, OR ANY EXTERNAL SYSTEM COMPONENTS (SUCH AS THE POWER MODULE, THE MOBILE POWER UNIT, BATTERIES, POWER CABLES, OR BATTERY CLIPS) INTO WATER OR LIQUID. SUBMERSION IN WATER OR LIQUID MAY CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A CONTROLLER EXCHANGE DUE TO A TEAR IN THE DRIVELINE COVER AT THE BEND RELIEF ON THE WHITE BATTERY CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326849 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male