BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 12693565 · Received October 25, 2021

    Report

    Report Number
    2916596-2021-05744
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 28, 2021
    Report Date
    January 18, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE ¿CONTROLLER HAD ONE SCREW THAT WOULD NOT SCREW IN¿ WAS CONFIRMED WITH THE RETURNED SYSTEM CONTROLLER (SERIAL # HSC-101685). VISUAL INSPECTION REVEALED ONE OF THE BATTERY COVER SCREWS WAS UNABLE TO BE SECURED. THE THREADS ON THE SCREW APPEAR UNREMARKABLE. VISUAL INSPECTION OF THE HELI COIL APPEARED TO BE DAMAGED/DEFORMED. A ROOT CAUSE OF THE DAMAGED/DEFORMED HELI COIL COULD NOT BE DETERMINED DURING THE EVALUATION. DEVICE HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED IN ACCORDANCE TO MFG AND QA SPECIFICATIONS. SYSTEM CONTROLLER (SERIAL # (B)(6) WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2021. 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¿ ALL ALARM CONDITIONS ARE ADDRESSED. HEARTMATE 3 INSTRUCTIONS FOR USE ¿REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN¿. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE VAD COORDINATOR WAS INSTALLING THE EMERGENCY BACKUP BATTERY INTO THE PRIMARY POCKET CONTROLLER AT THE END OF THE CASE, THE BACK OF THE CONTROLLER HAD ONE SCREW THAT WOULD NOT SCREW IN AT ALL. THE BACK OF THE BACKUP CONTROLLER WAS REMOVED TO SEE IF THE ISSUE WAS WITH THE CONTROLLER OR CONTROLLER BACK, AND THE SCREW WAS UNABLE TO SCREW IN, POINTING TO AN ISSUE WITH THE CONTROLLER HOLE ITSELF. THE REMAINING THREE SCREWS FUNCTIONED PROPERLY. A CONTROLLER EXCHANGE WAS PERFORMED IN THE OPERATING ROOM PRIOR TO TRANSFERRING TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS ISSUED A NEW PRIMARY AND BACKUP CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587860 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531US 7945783 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male