BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 19139419 · Received April 18, 2024

    Report

    Report Number
    2916596-2024-02233
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    April 2, 2024
    Report Date
    September 12, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A4: PATIENT INFORMATION NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF SURFACE WEAR ON THE MODULAR CABLE WAS NOT CONFIRMED. THERE WERE NO LOG FILES SUBMITTED FOR REVIEW. THE MOD CABLE, LOT 7210188, WAS NOT RETURNED FOR ANALYSIS. THE ADDITIONAL INFORMATION PROVIDED STATED THAT THE MODULAR CABLE WAS EXCHANGED DUE TO SURFACE WEAR. THE EXTENT OF THE DAMAGE TO THE CABLE OUTER JACKET IS UNKNOWN. THERE WERE NO ADVERSE EVENTS DUE TO THE OBSERVED DAMAGE. THE PROVIDED PICTURE OF THE PUMP CABLE SHOWED A SMALL PORTION OF THE MODULAR CABLE WHICH DID NOT SHOW ANY DAMAGE; HOWEVER, THE INLINE CONNECTOR STRAIN RELIEF WAS OBSERVED TO BE DISCOLORED. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS 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. THE HEARTMATE3 LVAS PATIENT HANDBOOK SECTION 10 ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE AND ENSURING THAT THE MODULAR IN-LINE CONNECTOR IS SECURE AND THE CONNECTOR LOCKING NUT IS IN THE LOCKED POSITION. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 2-¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 2-¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MODULAR CABLE WAS EXCHANGED.

    Description of Event or Problem · 0

    THE MODULAR CABLE HAD BEEN CHANGED DUE TO SURFACE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593419 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 7210188 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention