BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 15242869 · Received August 17, 2022

    Report

    Report Number
    2916596-2022-12657
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    May 17, 2021
    Report Date
    August 18, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY MEDWATCH FORM # 3400300000-2021-0000027 WAS RECEIVED ON 27JUL2022. 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 WHITE POWER LEAD BEING DAMAGED WAS NOT CONFIRMED. THE SYSTEM CONTROLLER (SERIAL NUMBER UNKNOWN) WAS NOT RETURNED FOR ANALYSIS, AND NO LOG FILES WERE ASSOCIATED WITH THE REPORTED EVENT. QUESTIONS REGARDING THE EVENT WERE ASKED MULTIPLE TIMES; HOWEVER, NO RESPONSES WERE RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE SERIAL NUMBER OF THE SYSTEM CONTROLLER WAS NOT PROVIDED. 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

    VOLUNTARY MEDWATCH WAS RECEIVED THAT STATED THE PATIENT ARRIVED TO CLINIC ON (B)(6) 2021 WITH THE WHITE LEAD OF THEIR CONTROLLER DAMAGED AND A SMALL TEAR ON THE SILICONE COVERING DISTAL TO THE MODULAR CABLE CONNECTOR. THE PATIENT'S DRIVELINE WAS FOUND TO BE UNLOCKED AT THE MODULAR CABLE CONNECTOR. THE CONTROLLER AND MODULAR CABLE WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541640 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male