BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 13446170 · Received February 3, 2022

    Report

    Report Number
    2916596-2022-00594
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 18, 2022
    Report Date
    April 25, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF DIFFICULTY CONNECTING AND DISCONNECTING THE MODULAR CABLE COULD NOT BE CONFIRMED THROUGH THIS EVALUATION, AS THE DEVICE REMAINS IN USE. A SPECIFIC CAUSE FOR THIS FINDING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT #8202842 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (HM3 LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. THE IFU CONTAINS INSTRUCTIONS FOR OBSERVING DAMAGE TO THE MODULAR CABLE AND REPLACING THE MODULAR CABLE IN THE SYSTEM OPERATIONS SECTION. THE INSTRUCTIONS STATE THAT THE LOCKING NUT MUST BE ROTATED UNTIL THE CLICKING STOPS AND THE YELLOW LINE IS HIDDEN. THE SURGICAL PROCEDURES SECTION PROVIDES INSTRUCTIONS FOR CONNECTING THE MODULAR CABLE TO THE PUMP CABLE UNDER ¿PREPARING, RUNNING, AND PRIMING THE PUMP.¿ AFTER SECURING THE CONNECTION, THE YELLOW LINE SHOULD BE FULLY COVERED TO ENSURE A SECURE CONNECTION. THE DAILY SAFETY CHECKLIST INCLUDES LINE ITEMS TO ENSURE THAT THE MODULAR IN-LINE CONNECTOR IS SECURE AND THE CONNECTOR LOCKING NUT IS IN THE LOCKED POSITION. ENSURE NO YELLOW INDICATOR IS SEEN UNDER THE IN-LINE LOCKING NUT. THE IFU ALSO WARNS THAT A COMPLETE BACKUP SYSTEM MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. 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

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2022-10466.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP MODULAR CABLE WAS DIFFICULT TO CONNECT AND DISCONNECT DURING HM3 PUMP PREP. THE MODULAR CABLE WAS ABLE TO BE DISCONNECTED AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175541 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525US 8202842 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male