BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 16387442 · Received February 16, 2023

    Report

    Report Number
    2916596-2023-00702
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 30, 2023
    Report Date
    April 10, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: INCIDENTAL FINDINGS: DAMAGE - SECONDARY PCB THE REPORTED EVENT OF THE CONTROLLER HAVING AN UNLIT LED ON ITS BATTERY GAUGE WAS CONFIRMED, AS ONE OF THE GREEN BATTERY GAUGE LEDS ON THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(6) ) WAS UNABLE TO LIGHT UP AS INTENDED THROUGHOUT TESTING. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND OPERATED A MOCK LOOP AS INTENDED DESPITE THE UNLIT LED. A LOG FILE WAS EXTRACTED FROM THE CONTROLLER DURING TESTING; HOWEVER, NO ATYPICAL EVENTS REGARDING THE CONTROLLER WERE OBSERVED, AND THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. THE UNLIT LED ON THE SYSTEM CONTROLLER WAS FOUND TO LIGHT UP WHEN PRESSURE WAS APPLIED TO THE COMPONENT AND RESUMED BEING UNLIT WHEN PRESSURE WAS LIFTED. THE LED WAS REPLACED WITH A NEW COMPONENT, AND FURTHER ISSUES WERE UNABLE TO BE REPRODUCED AFTER THIS REPLACEMENT, NARROWING THE ISSUE DOWN TO THE ORIGINAL LED. AFTER REPLACING THE LED, ALL BATTERY GAUGE LIGHTS FUNCTIONED AS INTENDED. THE ROOT CAUSE OF THE DAMAGE TO THE ORIGINAL LED WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED AT (B)(6) HOSPITAL IN (B)(6) JAPAN. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM CONTROLLER DID NOT ILLUMINATE ONE OF THE GREEN BARS ON THE BATTERY POWER GAUGE. THE CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390430 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8023776 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male