BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 19323631 · Received May 15, 2024

    Report

    Report Number
    2916596-2024-02698
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 26, 2024
    Report Date
    August 29, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D1 - BRAND NAME: CORRECTED. SECTION D4 - CATALOG NUMBER: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER OVERHEATING WAS NOT CONFIRMED. THERE WERE NO PHOTOS OR LOG FILES SUBMITTED FOR REVIEW. SYSTEM CONTROLLER, SERIAL (B)(6), WAS NOT RETURNED FOR ANALYSIS. THE PROVIDED INFORMATION STATED THAT THE CONTROLLER WAS GETTING HOT ENOUGH THAT IT WAS MELTING THE ANCHOR THAT WAS USED TO SECURE THE PERCUTANEOUS LEAD AND MODULAR CABLE. THE HEARTMATE 3 INSTRUCTIONS FOR USE EXPLAINS THAT THE SYSTEM CONTROLLER SURFACE TEMPERATURE CAN BECOME UNCOMFORTABLY WARM, ESPECIALLY WHEN THE ROOM TEMPERATURE IS ABOVE 104°F (40°C). MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING PICTURES AND LOG FILES; HOWEVER, NO RESPONSE WAS RECEIVED. A ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 2-¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 2-¿HOW YOUR HEART PUMP WORKS¿ URGES THE USER 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 (40°C). HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8-¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6-¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY TAKE CARE AND MAINTAIN THE INTEGRITY OF THE SYSTEM CONTROLLER. 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

    IT WAS REPORTED THAT THE SYSTEM CONTROLLER WAS GETTING HOT ENOUGH THAT IT WAS MELTING ANCHOR. PHOTOS AND LOG FILES WOULD BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520327 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female