BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE II®, SYSTEM CONTROLLER

    MDR report key: 18058328 · Received November 2, 2023

    Report

    Report Number
    2916596-2023-07422
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 11, 2023
    Report Date
    May 24, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D3, G1: UPDATED INFORMATION. SECTION D1: CORRECTED. SECTION D4, CATALOG NUMBER: CORRECTED. SECTION D4, PRIMARY UDI NUMBER: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    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; HOWEVER, A LOG FILE WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILES SHOWED EVENTS SPANNING APPROXIMATELY 7 DAYS (04OCT2023 ¿ 11OCT2023 PER TIMESTAMP). THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOGFILE. PUMP OPERATION WAS NOT AFFECTED, AND THE DEVICE APPEARED TO FUNCTION AS INTENDED. ADDITIONAL INFORMATION PROVIDED ON 16OCT2023 STATED THE CONTROLLER WILL NOT BE RETURNING; THEREFORE, THE CONTROLLER TEMPERATURE WAS UNABLE TO BE MEASURED. 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 AND 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 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 QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. 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. 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 · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM CONTROLLER FELT WARMER TO THE TOUCH THAN USUAL, HOWEVER IT WAS NOT EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927692 THORATEC® HEARTMATE II®, SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 6319520 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male