BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 21851298 · Received April 16, 2025

    Report

    Report Number
    2916596-2025-02161
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 25, 2025
    Report Date
    June 4, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF POWER FAULT ALARMS WAS CONFIRMED VIA LOG FILE ANALYSIS; HOWEVER, THE REPORTED EVENT WAS NOT REPRODUCED DURING TESTING OF THE RETURNED PRODUCT. LOG FILES WERE SUBMITTED AND DOWNLOADED FOR REVIEW AND DATA FROM THE REPORTED EVENT DATE OF 25MAR2025 WAS REVIEWED. STARTING AT 19:04:16, DRIVELINE POWER FAULT ALARMS ACTIVATED DUE TO A POWER A BROKEN FAULT. THE POWER A BROKEN FAULT ACTIVATED DUE TO THE CURRENT SENSE ON LINE A BEING LOWER THAN THE EXPECTED AMPERAGE THRESHOLD. THE DRIVELINE POWER FAULT ALARMS RESOLVED AT 21:28:30. PUMP OPERATION WAS NOT AFFECTED. INSPECTION OF THE RETURNED MODULAR CABLE (LOT NUMBER 9072145) REVEALED A WHITE SUBSTANCE AROUND THE BASE OF AN INLINE CONNECTOR PIN; THIS COULD HAVE CONTRIBUTED TO THE REPORTED ALARMS. THE MODULAR CABLE WAS FUNCTIONALLY TESTED AND OPERATED AS INTENDED DURING TESTING. THE INTEGRITY OF THE WIRES IN THE MODULAR CABLE WERE THEN TESTED AND THE CABLE PASSED TESTING WITHOUT ANY ISSUES. THE MODULAR CABLE WAS THEN CONNECTED TO A TEST SYSTEM CONTROLLER, AND A TEST PUMP, AND SUCCESSFULLY OPERATED THE TEST PUMP FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED, INCLUDING WHEN THE MODULAR CABLE WAS MANIPULATED BY HAND. THE ROOT CAUSE OF THE DRIVELINE POWER FAULT ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) IFU SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ COVERS ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING DRIVELINE POWER FAULT ALARMS, AND THE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. SUBSECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES", EXPLICITLY CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. HEARTMATE 3 LVAS IFU, SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿, EXPLAINS HOW TO PROPERLY CARE FOR THE EQUIPMENT, INCLUDING THE CONTROLLER AND THE MODULAR CABLE. HEARTMATE 3 LVAS IFU, 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 LVAS IFU CAUTIONS 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. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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 PATIENT CALLED THE HOSPITAL DUE TO A POWER FAULT ALARM ON THEIR SYSTEM CONTROLLER. DEVICE INTERROGATION CONFIRMED THE POWER FAULT ALARM. LOG FILES SHOWED A SUDDEN INCREASE IN RESISTANT IN LINE A, WHICH TRIGGERED THE ALARM. THE ALARM WAS CLEARED, AND THE POWER FAULT ALARM DID NOT RETURN. MODULAR CABLE AND THE SYSTEM CONTROLLER WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114850 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 9072145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male