BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17577319 · Received August 18, 2023

    Report

    Report Number
    2916596-2023-06040
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 18, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE OUTER LAYER OF THE MODULAR CABLE (LOT NUMBER: 7190963) BEING DAMAGED WAS CONFIRMED DURING EVALUATION OF THE RETURNED PRODUCT. A SMALL TEAR IN THE OUTER JACKET WAS OBSERVED, WHICH EXPOSED THE INNER WOVEN LAYER. THE MODULAR CABLE WAS FUNCTIONALLY TESTED ALONGSIDE THE RETURNED CONTROLLER AND FOUND TO PERFORM AS INTENDED, EVEN WHEN THE CABLE WAS MANIPULATED BY HAND IN THE AREA OF THE OBSERVED DAMAGE. AFTER FUNCTIONAL TESTING, THE OUTER JACKET WAS REMOVED IN THE AREA OF THE OBSERVED DAMAGE. THE INNER WOVEN LAYER WAS NOT DAMAGED, BUT DID HAVE SOME GREENISH DISCOLORATION, INDICATING THAT THERE WAS FLUID INGRESS WITHIN THE JACKET THE ROOT CAUSE OF THE OBSERVED DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THAT THE HEARTMATE 3 MODULAR CABLE (LOT #: 7190963) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK (REV. D) ARE CURRENTLY AVAILABLE. THE IFU AND PATIENT HANDBOOK CONTAINS INFORMATION ON CARING FOR THE DRIVELINE IN SECTION 4 ¿LIVING WITH THE HEARTMATE 3". IN SEVERAL SECTIONS, THIS DOCUMENT WARNS THE USER TO NEVER PUT THE DRIVELINE, SYSTEM CONTROLLER, OR ANY EXTERNAL EQUIPMENT INTO WATER OR LIQUID; IMMERSION IN WATER OR LIQUID MAY CAUSE THE PUMP TO STOP. SECTION 4 "LIVING WITH THE HEARTMATE 3" OF THE PATIENT HANDBOOK CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THE HEARTMATE III INSTRUCTIONS FOR USE (REV. C - SECTION 8) AND THE HEARTMATE III PATIENT HANDBOOK (REV. D ¿ SECTION 6) ADDRESS HOW TO STORE, MAINTAIN, AND CARE FOR ALL EQUIPMENT, INCLUDING THE MODULAR CABLE. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMALL TEAR WAS NOTICED ON THE PATIENT'S MODULAR CABLE, AND IT WAS EXCHANGED. EVALUATION OF THE RETURNED MODULAR CABLE REVEALED FLUID INGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329782 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7190963 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male