BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 19795681 · Received July 22, 2024

    Report

    Report Number
    2916596-2024-04384
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 19, 2024
    Report Date
    September 24, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED DAMAGE TO THE MODULAR CABLE WAS NOT CONFIRMED AS NO IMAGES WERE SUBMITTED AND THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR 6930554 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) REV. C, AND THE HEARTMATE 3 PATIENT HANDBOOK REV. D, ARE CURRENTLY AVAILABLE. THE PATIENT HANDBOOK CAUTIONS THE USER 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. SECTION 2 OF THE IFU EXPLAINS THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED AND PROVIDES INSTRUCTIONS ON HOW TO DO SO. THE IFU AND PATIENT HANDBOOK CONTAIN INFORMATION ON HOW TO CLEAN AND CARE FOR THE DRIVELINE. SECTION 6 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO STATES, ¿CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK PROVIDE ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN SUB-SECTIONS ENTITLED, "WHAT NOT TO DO: DRIVELINE AND CABLES". FURTHERMORE, SECTION 8 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH AND IF MORE AGGRESSIVE CLEANING IS NEEDED, TO USE WARM WATER AND MILD DISH SOAP. 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 COMPLETE.

    Description of Event or Problem · 0

    THE ALARMS WERE THOUGHT TO BE DUE TO THE MODULAR CABLE BEING TORN WHICH CAUSED DAMAGE TO THE CABLE. THE MODULAR CABLE DAMAGE WAS COSMETIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD INTERMITTENT POWER CABLE DISCONNECT ALARMS WHEN THE PATIENT CONNECTED TO THE BATTERY. IT WAS NOTED THAT THE PATIENT TAPED THE DRIVELINE AND CONNECTED TO HELP WITH MANUAL DEXTERITY. ADDITIONAL INFORMATION RECEIVED ON 27JUN2024 REPORTED THE ALARMS WERE DUE TO MODULAR CABLE BEING TORN WHICH CAUSED COSMETIC DAMAGE TO THE CABLE. THE EVENT LOG FILES CAPTURED CONNECTION AND VOLTAGE ISSUES ON THE BATTERY AND MOBILE POWER UNIT. THE SYSTEM CONTROLLER AND THE SYSTEM MODULAR CABLE WERE EXCHANGED WHICH RESOLVED THE ISSUE. THE BATTERIES AND BATTERY CLIPS WERE INSPECTED AND WERE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119517 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 6930554 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male