BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 12651802 · Received October 18, 2021

    Report

    Report Number
    2916596-2021-05631
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 22, 2021
    Report Date
    November 15, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER¿S WHITE POWER CABLE BEING DAMAGED, CAUSING LOW VOLTAGE/POWER CABLE DISCONNECT/NO EXTERNAL ALARMS, WAS CONFIRMED. THE PROVIDED LOG FILE FROM THE RETURNED SYSTEM CONTROLLER CONTAINED DATA SPANNING APPROXIMATELY 5 DAYS (B)(6) 2021 PER TIME STAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. LOW VOLTAGE, POWER CABLE DISCONNECT, AND NO EXTERNAL POWER ALARMS WERE ALL INTERMITTENTLY OBSERVED BEGINNING ON (B)(6) 2021 AT 12:21, CAUSED BY THE VOLTAGE FLUCTUATING AROUND THE ALARM THRESHOLDS. THESE ALARMS REMAINED ACTIVE UNTIL THE CONTROLLER WAS SHUT DOWN SOMETIME AFTER 12:36 OF THE SAME DAY. THE CONTROLLER WAS OBSERVED TO HAVE BEEN POWERED ON AGAIN ON (B)(6) 2021 IN ORDER TO RETRIEVE THE LOG FILE. NO OTHER NOTABLE EVENTS WERE OBSERVED. THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(6) WAS OBSERVED TO HAVE A DAMAGED WHITE POWER CABLE UPON ARRIVAL. THE INNER WIRING COULD BE SEEN WITHIN THE DAMAGE, AND THE GREEN AND GRAY INNER WIRES (POSITIVE POWER LINES) WERE ALSO OBSERVED TO BE DAMAGED. THE CONTROLLER WAS FUNCTIONALLY TESTED AND WAS FOUND TO ALARM WITH LOW VOLTAGE/POWER CABLE DISCONNECT/NO EXTERNAL ALARMS UPON MANIPULATING ITS WHITE POWER CABLE, AS THE OBSERVED DAMAGED CONDUCTORS WERE SHORTING TO THE CABLE¿S SHIELDING. THE CONTROLLER¿S POWER CABLES WERE REPLACED WITH TEST CABLES, AND THE CONTROLLER WAS FUNCTIONALLY TESTED AND WAS FOUND TO PERFORM AS INTENDED WHEN TEST CABLES WERE IN USE. THE ROOT CAUSE OF THE DAMAGE TO THE WHITE POWER CABLE WAS CAUSED BY THE PATIENT PER THE REPORTED EVENT. THE HEARTMATE 3 PATIENT HANDBOOK INSTRUCTS USERS TO REGULARLY INSPECT THEIR EQUIPMENT, INCLUDING THEIR SYSTEM CONTROLLERS, AND TO AVOID USING EQUIPMENT THAT APPEARS DAMAGED. USERS ARE ENCOURAGED TO REPLACE ANY EQUIPMENT THAT APPEARS DAMAGED. THE HEARTMATE 3 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. REVIEW OF THE DEVICE HISTORY RECORD FOR THE SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT HAD SURGERY RELATED TO A DRIVELINE INFECTION. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED POSTOPERATIVE/POST-ANESTHETIC PSYCHOSIS AND BEGAN TUGGING AT THE SYSTEM CONTROLLER'S POWER CABLES, EVENTUALLY CHEWING ON THE CONNECTOR ON THE WHITE POWER CORD. AS A RESULT, THERE WAS AN INTERRUPTION IN THE POWER SUPPLY FROM THE POWER MODULE AS WELL AS THE 14V BATTERIES. THE CONTROLLER WAS EXCHANGED. RELATED MFR NUMBER: 2916596-2021-05630.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547826 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531US 7601632 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 Male