BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 10579429 · Received September 24, 2020

    Report

    Report Number
    2916596-2020-04744
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    June 15, 2020
    Report Date
    September 24, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE PATIENT EXPERIENCING SHORTER BATTERY RUNTIMES WITH THE CONTROLLER¿S BLACK CABLE WAS CONFIRMED. THE PROVIDED LOG FILE CONTAINED DATA SPANNING APPROXIMATELY 13 DAYS (02JUN2020 ¿ 15JUN2020 PER TIME STAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. THE PATIENT¿S VOLTAGE VALUES WERE OBSERVED TO BE BELOW AVERAGE THROUGHOUT THE LOG FILE ON EITHER BATTERIES OR THE POWER MODULE PATIENT CABLE. THE RSOC VALUES ON THE BLACK CABLE WERE OBSERVED TO BE CONSISTENTLY LOWER THAN THE WHITE CABLE¿S WHILE BATTERIES WERE IN USE, TRIGGERING POWER CABLE DISCONNECT AND LOW VOLTAGE ALARMS. ALTHOUGH LOW VOLTAGES WERE OBSERVED ON THE POWER MODULE, ATYPICAL ALARMS DID NOT OCCUR WHILE IT WAS IN USE. NO OTHER NOTABLE EVENTS WERE OBSERVED. THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(4)) WAS FUNCTIONALLY TESTED, AND WAS FOUND TO HAVE INCREASED RESISTANCES WITHIN ITS POWER CABLES, CAUSING LOW VOLTAGE OUTPUT (13.1 ¿ 13.5 VOLTS WHILE CONNECTED TO THE TEST POWER MODULE AND PATIENT CABLE). DESPITE THIS, THE CONTROLLER OPERATED A MOCK LOOP AS INTENDED. EVERY WIRE WITHIN BOTH CABLES WAS INDIVIDUALLY MEASURED, AND EVERY WIRE HAD ABOVE-AVERAGE RESISTANCES, RANGING FROM 1.0 ¿ 4.8 OHMS. AS THE FINDINGS WITHIN THE LOG FILE WERE CONSISTENT WITH THE TESTING OF THE CONTROLLER, THE ROOT CAUSE OF THE REPORTED EVENT WAS CONDUCTOR BREAKDOWN WITHIN THE CONTROLLER¿S POWER CABLES. INCIDENTAL FINDINGS: DIM GREEN PUMP LEDS. THE HEARTMATE II PATIENT HANDBOOK INSTRUCTS USERS TO NOT TWIST, KINK, OR OTHERWISE BEND THEIR SYSTEM CONTROLLER¿S POWER CORDS IN A WAY THAT MAY DAMAGE THEM. THE HEARTMATE II PATIENT HANDBOOK CAUTIONS 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SHORTER BATTERY TIMES (AROUND 4 HOURS MAXIMUM) WHEN ATTACHED TO THE BLACK LEAD OF THE POCKET CONTROLLER. THE BATTERIES WERE REPLACED IN MARCH. THE PATIENT REPORTED THAT THE ISSUE REMAINED WITH BLACK LEAD WHEN ATTACHED TO BATTERIES ONLY. A REVIEW OF THE LOG FILE NOTED LONG STRINGS OF EITHER ODD VOLTAGES OR NO VOLTAGE ON THE BLACK POWER LEAD OF THE CONTROLLER. TECHNICAL SUPPORT RECOMMENDED THAT THE ACCOUNT CHECK THE CONNECTOR OF THE BLACK LEAD AND THE BATTERY CLIP CONNECTORS FOR ANY BENT OR BROKEN PINS. TECHNICAL SUPPORT RECOMMENDED EXCHANGING THE BATTERY CLIPS FIRST, THEN EXCHANGING THE CONTROLLER IF THE BATTERY CLIP EXCHANGE DID NOT RESOLVE THE ISSUE. TECHNICAL SUPPORT ALSO NOTED SOME VOLTAGES BELOW SPECIFICATIONS WHILE USING THE PATIENT CABLE. TECHNICAL SUPPORT RECOMMENDED EXCHANGING THE PATIENT CABLE AS WELL. THE PATIENT HAD TRIED DIFFERENT BATTERY CLIPS. THERE WAS NO VISUAL DAMAGE NOTED ON ANY OF THE PATIENT'S EQUIPMENT. THE ACCOUNT NOTED THAT THE PATIENT'S CONTROLLER WOULD LIKELY BE EXCHANGED ONCE THE PATIENT INTERNATIONAL NORMALIZED RATIO (INR) LEVELS CAME UP. THE PATIENT WAS ADMITTED FOR AN UNRELATED ISSUE. THE CONTROLLER WAS EXCHANGED. NO ALARMS WERE ASSOCIATED WITH THE EVENT. THE PATIENT WAS JUST EXPERIENCING SHORTER BATTERY LIFE ON THE BLACK LEAD OF THE CONTROLLER. THE PATIENT CABLE WAS NOT EXCHANGED. EVENTS WERE HAPPENING ONLY ON BATTERY POWER. THE CONTROLLER WILL BE RETURNED. THE PATIENT REPORTED SHORTER BATTERY LIFE FROM THE BLACK CONTROLLER LEAD. LOG FILES WERE SENT FOR ANALYSIS. THE LOG FILE CAPTURED LONG ODD STRINGS OF ODD VOLTAGES OR NO VOLTAGE ON THE BLACK POWER LEAD OF THE CONTROLLER. THE CONTROLLER WAS EXCHANGED WHILE INPATIENT. THE PATIENT WAS STABLE AND ASYMPTOMATIC. THE PATIENT WAS TREATED FOR ADMITTING DIAGNOSES. THE PUMP PARAMETERS WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048496 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR