BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 9962979 · Received April 15, 2020

    Report

    Report Number
    2916596-2020-01896
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    March 25, 2020
    Report Date
    August 12, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4 AND H6 (DEVICE CODE): CORRECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: ALTHOUGH THE EVALUATION OF THE SUBMITTED LOG FILES IDENTIFIED A COMMUNICATION FAULT ALARM, A SPECIFIC CAUSE FOR THIS FINDING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE EVALUATION OF THE SUBMITTED LOG FILES REVEALED ONE DRIVELINE COMMUNICATION FAULT ALARM STARTING ON (B)(6) 2020 AT 11:57:22. THIS ALARM PERSISTED UNTIL IT WAS CLEARED AT 11:59:56, AND NO FURTHER DRIVELINE COMMUNICATION FAULT EVENTS WERE OBSERVED THROUGHOUT THE REMAINDER OF THE DATA. DESPITE THIS FINDING, THE PUMP APPEARED TO HAVE FUNCTIONED AS INTENDED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE DURATION OF THE SUBMITTED DATA. TECHNICAL SERVICES RECOMMENDED INSPECT THE MODULAR CABLE FOR ANY DAMAGE. IT WAS ALSO RECOMMENDED TO REPLACE THE MODULAR CABLE AND CONTROLLER TO POTENTIALLY RESOLVE THE ISSUE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE ISSUED TO THE CUSTOMER; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED TO THIS DATE. ADDITIONALLY, MODULAR CABLE, LOT NUMBER 7232316, WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION FILE WILL BE CLOSED ACCORDINGLY. THE PATIENT REMAINS ONGOING AND NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER'S REPORT NUMBER: 2916596-2020-02873.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A LOG FILE ANALYSIS WAS PERFORMED AND FOUND A FEW SUSPECT CURRENT DROPS IN THE MODULAR CABLE. THE MODULAR CABLE WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424973 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525 7232316

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention HEARTMATE 3 LVAS IMPLANT KIT.