BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 22125206 · Received June 2, 2025

    Report

    Report Number
    2916596-2025-03176
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    April 30, 2025
    Report Date
    July 21, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE LOT NUMBER WAS NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED SUPERFICIAL DAMAGE TO THE MODULAR CABLE OUTER JACKET COULD NOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR EVALUATION AND NO IMAGES WERE SUBMITTED FOR REVIEW. FURTHER, A SPECIFIC CAUSE FOR THE REPORTED DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE SUBMITTED CONTROLLER EVENT AND PERIODIC LOG FILES CAN BE FOUND UNDER PI-2025-0070255-01. REVIEW OF THE LEFT VENTRICULAR ASSIST DEVICE EVENT AND PERIODIC LOG FILES CAPTURED THE PUMP FUNCTIONING AS INTENDED AND DID NOT INDICATE AN ELECTRICAL ISSUE WITH THE MODULAR CABLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE ACCOUNT. THE PATIENT REMAINS ONGOING ON LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SUPPORT WITH NO FURTHER EVENTS REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MODULAR CABLE WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THE PATIENT HANDBOOK CAUTIONS 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. SECTION 2 OF THE IFU, ¿SYSTEM OPERATIONS,¿ EXPLAINS THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED, AND PROVIDES INSTRUCTIONS ON HOW TO DO SO. THE IFU AND PATIENT HANDBOOK CONTAIN INFORMATION ON HOW TO CLEAN AND CARE FOR THE DRIVELINE. SECTION 6 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO KEEP THE DRIVELINE CLEAN AND CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO STATES, ¿CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK PROVIDE ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN SUB-SECTIONS ENTITLED, "WHAT NOT TO DO: DRIVELINE AND CABLES.¿ FURTHERMORE, SECTION 8 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH AND IF MORE AGGRESSIVE CLEANING IS NEEDED, TO USE WARM WATER AND MILD DISH SOAP. 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 PATIENT'S MODULAR CABLE WAS EXCHANGED. THE MODULAR CABLE WAS NOTED TO HAVE HAD ELECTRICAL TAPE OVER A PORTION OF THE LINE AND DATA WAS NOT TRANSMITTING TO THE CLINICAL SCREEN. THE MODULAR CABLE WAS NOTED TO BE INTACT AND TIGHT. THE EVENT LOG CAPTURED ODD TIMESTAMPS AND COMM A AND B FAULTS IN THE BACKGROUND PRIOR TO THE DRIVELINE DISCONNECT EVENT ASSOCIATED WITH THE MODULAR CABLE EXCHANGE ON (B)(6) 2025 AT 13:05. IT WAS NOTED THAT IF BOTH COMM A AND B FAULTS WERE TO OCCUR THAN THE SYSTEM CONTROLLER WOULD HAVE NO DATA SHOWING AND EVERY PARAMETER WOULD BE DISPLAYED AS 0. IT WAS NOTED THAT ONCE THE DRIVELINE WAS DISCONNECTED AND RECONNECTED THE COMM FAULTS RESOLVED AND THE VENTRICULAR ASSIST DEVICE NUMBERS APPEARED TO HAVE RETURNED TO BASELINE NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S MODULAR CABLE WAS EXCHANGED. THE MODULAR CABLE WAS NOTED TO HAVE HAD ELECTRICAL TAPE OVER A PORTION OF THE LINE AND DATA WAS NOT TRANSMITTING TO THE CLINICAL SCREEN. THE MODULAR CABLE WAS NOTED TO BE INTACT AND TIGHT. ON (B)(6) 2025 THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292001 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male