BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 18482952 · Received January 10, 2024

    Report

    Report Number
    2916596-2023-08919
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 21, 2023
    Report Date
    April 16, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE HEARTMATE 3 MODULAR CABLE WAS RETURNED FOR EVALUATION FOLLOWING THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS; HOWEVER, IT WAS DETERMINED THAT THE MODULAR CABLE WAS UNRELATED TO THE CAUSE OF THE REPORTED EVENT. THE RETURNED MODULAR CABLE (LOT NUMBER: 9213780) WAS FUNCTIONALLY TESTED AND OPERATED AS INTENDED DURING TESTING. THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE RETURNED SYSTEM CONTROLLER AND NOT CORRELATED TO AN ISSUE WITH THE RETURNED MODULAR CABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE HEARTMATE 3 MODULAR CABLE, LOT NUMBER 9213780, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE MODULAR CABLE WAS SHIPPED TO THE CUSTOMER ON 14DEC2023. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ SUBSECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES", EXPLICITLY CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. HEARTMATE 3 PATIENT HANDBOOK SECTION 4 ¿ ¿LIVING WITH THE HEARTMATE 3¿ EXPLAINS HOW TO PROPERLY CARE FOR THE DRIVELINE AND STATES, ¿KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID¿. HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ¿ ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF 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 DURING IMPLANT, THE CONTROLLER HAD A DRIVELINE POWER FAULT ALARM. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. THIS RESOLVED THE ISSUE. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2023-08918 (SYSTEM CONTROLLER)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143020 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 9213780 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male