BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 18184648 · Received November 21, 2023

    Report

    Report Number
    2916596-2023-07884
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    November 2, 2023
    Report Date
    January 17, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BROKEN PIN IN THE SYSTEM CONTROLLER¿S WHITE POWER LEAD WAS NOT CONFIRMED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, INCLUDING IF THE BROKEN PIN WAS FOUND IN THE CONNECTOR OF A POWER SOURCE SUCH AS THE POWER MODULE, MOBILE POWER UNIT, OR BATTERY CLIP CONNECTOR, AND IF ANY PRODUCTS WOULD BE RETURNED FOR ANALYSIS; 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 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE SYSTEM CONTROLLER WAS SHIPPED TO THE CUSTOMER ON 01MAY2023. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ ¿CARING FOR EQUIPMENT¿ EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT, INCLUDING THE CONTROLLER AND THE POWER CABLES. HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ "CARING FOR THE EQUIPMENT" DESCRIBES HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER POWER CABLES. THIS SECTION ALSO EXPLAINS THE IMPORTANCE OF PROTECTING THE SYSTEM CONTROLLER POWER CABLES FROM KINKS, SHARP BENDS, AND REPEATED BENDING. SECTION 10, ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE SYSTEM CONTROLLER POWER CABLES FOR DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION THE USER 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 ON 02NOV2023, ONE OF THE PINS IN THE WHITE POWER LEAD BROKE OFF. A SYSTEM CONTROLLER EXCHANGE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087937 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 9008441 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male