BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 16763753 · Received April 18, 2023

    Report

    Report Number
    2916596-2023-02293
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 22, 2023
    Report Date
    May 2, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    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

    RELATED MFR FOR THE CONTROLLER: 2916596-2023-02355. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    H6 - INVESTIGATION FINDINGS- USAGE PROBLEM IDENTIFIED (4248) MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE DRIVELINE NOT BEING COMPLETELY ENGAGED TO THE CONTROLLER WAS NOT CONFIRMED. THE CONTROLLER EVENT LOG FILE CONTAINED EVENTS FROM (B)(6) 2023 THROUGH (B)(6) 2023. THE DRIVELINE REMAINED CONNECTED TO THE SYSTEM CONTROLLER THROUGHOUT THE DURATION OF THE FILE, AND THERE WERE NO INTERRUPTIONS IN PUMP SUPPORT OBSERVED. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MODULAR CABLE LOT NUMBER 6747189 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 2 OF THE IFU, ¿SYSTEM OPERATIONS¿, INSTRUCTS THE USER HOW TO CORRECTLY INSERT THE DRIVELINE INTO THE SYSTEM CONTROLLER, STATING ¿INSERT THE DRIVELINE CABLE CONNECTOR INTO THE SOCKET, PRESSING FIRMLY UNTIL IT SNAPS INTO PLACE. MOVE THE SAFETY LOCK TO THE LOCKED POSITION, SO THAT IT COVERS THE RED BUTTON.¿ THIS SECTION ALSO WARNS THAT THE LEFT VENTRICULAR ASSIST DEVICE STOPS IF THE DRIVELINE IS DISCONNECTED FROM THE SYSTEM CONTROLLER. SECTION 2 OF THE PATIENT HANDBOOK, ¿HOW YOUR HEART PUMP WORKS¿, WARNS THE USER TO ¿CHECK THE SYSTEM CONTROLLER DRIVELINE CONNECTOR OFTEN TO CONFIRM THAT THE DRIVELINE IS SECURELY INSERTED IN THE SOCKET. IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP WILL STOP.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE NO EXTERNAL POWER(NEP) ALARMS. THE PATIENT WAS ADAMANT THAT THEY DID NOT DOUBLE DISCONNECT IN ANY WAY. IT WAS ALSO NOTED THAT THERE WERE NO ELECTRICAL FAULTS AND THE PATIENT ARRIVED TO THEIR APPOINTMENT WITH THEIR DRIVELINE NOT COMPLETELY ENGAGED IN THEIR SYSTEM CONTROLLER WITH A RED WINDOW EXPOSED ON THE BACK OF THEIR SYSTEM CONTROLLER. THE LOG FILES CAPTURED NO EXTERNAL POWER(NEP) EVENTS ON (B)(6)2023 AT 8:05 AND 8:06. THEY ALSO CAPTURED SOME ON (B)(6) 2023 AT 0:25 AND (B)(6) 2023 AT 4:04. THE NEPS APPEARED TO BE CAUSED BY AN INTERMITTENT WEAK CONNECTION BETWEEN THE BATTERIES AND CLIPS WHILE THE PATIENT SLEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540262 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 6747189 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female