BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 16977930 · Received May 22, 2023

    Report

    Report Number
    2916596-2023-02855
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    October 11, 2021
    Report Date
    May 25, 2023
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY MW NUMBER 3400300000-2022-0000012 WAS RECEIVED ON (B)(6) 2023. 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 A CONTROLLER ALARM WAS UNABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) WAS NOT RETURNED FOR ANALYSIS. NO LOG FILES WERE SUBMITTED FOR REVIEW; THEREFORE, THE EXACT ALARMS THAT WERE ACTIVE WERE UNABLE TO BE DETERMINED. MULTIPLE GOOD FAITH EFFORT ATTEMPTS WERE MADE ASKING IF THE CONTROLLER EXCHANGE RESOLVED THE ALARMS, AND IF ANY PRODUCTS WILL BE RETURNING; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. HEARTMATE III INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. THE PATIENT HANDBOOK CAUTIONS THE 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 RECEIVED THAT STATES THAT THE PATIENT PRESENTED WITH A CONTROLLER FAULT SOUND. THE PATIENT'S SYSTEM CONTROLLER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862915 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7202359 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female