BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 12732729 · Received November 1, 2021

    Report

    Report Number
    2916596-2021-05991
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 5, 2021
    Report Date
    January 20, 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

    MANUFACTURER'S INVESTIGATION CONCLUSION: DAMAGE AND DISCOLORATION WERE OBSERVED ON THE RETURNED MODULAR CABLE, LOT 181912. THE MODULAR CABLE WAS OPERATED ON A MOCK CIRCULATORY LOOP AND NO ALARM WAS REPRODUCED. THE INTEGRITY OF THE INTERNAL WIRES OF THE MODULAR CABLE WAS TESTED WHICH PASSED WITHOUT ANY ISSUE. THE DAMAGED MODULAR CABLE WAS A COSMETIC DAMAGE THAT DID NOT AFFECT ITS FUNCTIONALITY. A ROOT CAUSE OF THE REPORTED EVENT WAS NOT DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PATIENT HANDBOOK CAUTIONS THE 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. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 5 "SURGICAL PROCEDURES" CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 "PATIENT CARE AND MANAGEMENT" CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS SECTION FURTHER CAUTIONS: "DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, THE POWER MODULE PATIENT CABLE, OR THE MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN." SECTION 6 (UNDER "CARING FOR THE DRIVELINE") INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 7 "ALARMS AND TROUBLESHOOTING" PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". SECTION 8 "EQUIPMENT STORAGE AND CARE" (UNDER "CLEANING THE DRIVELINE") STATES, "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2021-05987. IT WAS REPORTED THAT THE PATIENT WAS SEEN AT THE HOSPITAL FOR A TRANSPLANT EVALUATION. A SYSTEM CONTROLLER AND MODULAR CABLE EXCHANGE TOOK PLACE WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630373 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525 181912 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female