BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 12733074 · Received November 1, 2021

    Report

    Report Number
    2916596-2021-06048
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    February 29, 2020
    Report Date
    November 30, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013013
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER OVERHEATING WAS UNABLE TO BE CONFIRMED. THE HEARTMATE II SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) WAS NOT RETURNED FOR ANALYSIS. MULTIPLE GOOD FAITH EFFORT ATTEMPTS WERE MADE REQUESTING IF THE SYSTEM CONTROLLER WILL BE RETURNING; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) AND WAS FOUND TO PASS ALL MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER ON (B)(6) 2019. HEARTMATE II INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 6 ENTITLED CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE. HEARTMATE II INSTRUCTIONS FOR USE SECTION 2 ENTITLED ¿SYSTEM OPERATIONS¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 2 ENTITLED ¿HOW YOUR HEART PUMP WORKS¿ STATES THAT THE ACCEPTABLE TEMPERATURE RANGE FOR THE SYSTEM CONTROLLER IS 32°F - 104°F. IT ALSO CAUTIONS USERS TO ¿NOT PLACE THE SYSTEM CONTROLLER ON BARE SKIN FOR AN EXTENDED TIME. THE SYSTEM CONTROLLER SURFACE TEMPERATURE CAN BECOME UNCOMFORTABLY WARM, ESPECIALLY WHEN THE ROOM TEMPERATURE IS ABOVE 104°F)¿. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYSTEM CONTROLLER WAS HOT. THEY HAD A CONTROLLER EXCHANGE ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629440 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106762 00813024013013

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male