BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 16272568 · Received January 31, 2023

    Report

    Report Number
    2916596-2023-00660
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    November 30, 2021
    Report Date
    February 21, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY MW NUMBER 3400300000-2021-0000041 WAS RECEIVED 26JAN2023 MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DAMAGE ON THE POWER CABLES WAS NOT CONFIRMED. IT WAS REPORTED THAT THE HEARTMATE II SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) WAS EXCHANGED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE MADE DETERMINE IF THE EXCHANGED CONTROLLER WOULD BE RETURNED FOR EVALUATION; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE HEARTMATE II SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE II SYSTEM CONTROLLER WAS SHIPPED TO THE CUSTOMER ON 07MAR2016. HEARTMATE II PATIENT HANDBOOK (REV. C) SECTION 6, ENTITLED "CARING FOR THE EQUIPMENT", DESCRIBES HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER POWER CABLES. SECTION 10, ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE II LVAD, INCLUDING INSPECTING THE SYSTEM CONTROLLER POWER CABLES FOR DAMAGE. THE HEARTMATE II PATIENT HANDBOOK (REV. C) 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

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

    Description of Event or Problem · 0

    T WAS REPORTED THAT THE PATIENT ARRIVED AT THE CLINIC ON (B)(6) 2021 WITH DAMAGE TO THE SYSTEM CONTROLLER POWER LEADS. THE SYSTEM CONTROLLER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790386 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male