BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 15214001 · Received August 11, 2022

    Report

    Report Number
    2916596-2022-12582
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    July 26, 2022
    Report Date
    August 22, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER¿S BLACK POWER CABLE BEING DAMAGED, RESULTING IN ATYPICAL ALARMS, WAS CONFIRMED. A LOG FILE WAS EXTRACTED FROM THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(6) CONTAINING DATA SPANNING APPROXIMATELY 2 DAYS (B)(6) 2022 ¿ (B)(6) 2022 PER TIMESTAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. ATYPICAL POWER CABLE DISCONNECT ALARMS WERE OBSERVED THROUGHOUT THE DATA CORRELATING TO THE BLACK POWER CABLE (RSOC INVALID FAULTS THAT WERE NOT ASSOCIATED WITH A POWER SOURCE EXCHANGE). LOW VOLTAGE AND NO EXTERNAL POWER ALARMS WERE ALSO OBSERVED WHEN THE WHITE CABLE WAS DISCONNECTED FROM POWER WHILE A BLACK CABLE FAULT WAS ACTIVE. THE RETURNED SYSTEM CONTROLLER WAS OBSERVED TO HAVE CUTS IN ITS BLACK POWER CABLE JACKET UPON ARRIVAL. THE BLACK POWER LEAD WAS ALSO OBSERVED TO HAVE BEEN DAMAGED, REVEALING INNER WIRING. UPON BEING CONNECTED TO A MOCK LOOP, A POWER CABLE DISCONNECT ALARM CORRELATING TO THE BLACK CABLE BECAME ACTIVE, AND LOW VOLTAGE ALARMS WERE OBSERVED WHEN THE WHITE CABLE WAS DISCONNECTED FROM POWER, CONSISTENT WITH THE LOG FILE OBSERVATIONS. THE CONTROLLER¿S POWER CABLES WERE REPLACED WITH TEST CABLES, RESOLVING THE ALARMS. THEN, THE CONTROLLER WAS FUNCTIONALLY TESTED WITH TEST POWER CABLES AND WAS FOUND TO PERFORM AS INTENDED. THE CONTROLLER¿S ORIGINAL POWER CABLES WERE ALSO MEASURED, AND OPEN LINES THAT WOULD HAVE CAUSED THE ALARMS TO OCCUR WERE OBSERVED IN THE BLACK CABLE. THE ROOT CAUSE OF THE REPORTED ALARMS WAS DETERMINED TO BE DAMAGE TO THE BLACK POWER CABLE; HOWEVER, THE ROOT CAUSE OF THE CABLE¿S DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR SYSTEM CONTROLLER, SERIAL NUMBER HSC-077856, SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D, SECTION 5 ¿ALARMS AND TROUBLESHOOTING) INSTRUCTS USERS ON HOW TO RESOLVE ALARMS THAT SOUND FROM THEIR SYSTEM CONTROLLER, INCLUDING ALARMS ASSOCIATED WITH LOW VOLTAGE/POWER CABLE DISCONNECT/NO EXTERNAL POWER CONDITIONS. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D, SECTION 10 ¿SAFETY CHECKLISTS¿) 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 (REV. D, SECTION TITLED "EMERGENCY CONTACT LIST") 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 THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD EXPOSED WIRES ON THE BLACK CONTROLLER POWER CABLE. AN ADVISORY ALARM WAS OCCURRING. THE PATIENT'S MOTHER PERFORMED A CONTROLLER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133231 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531 7048989 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male