BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 18851086 · Received March 6, 2024

    Report

    Report Number
    2916596-2024-01404
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 22, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE SUBMITTED PHOTOS CONFIRMED THE REPORTED SUPERFICIAL DAMAGE TO THE PATIENT¿S MODULAR CABLE; HOWEVER, A SPECIFIC CAUSE FOR THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. NO ALARMS WERE REPORTED IN ASSOCIATION WITH THIS EVENT. THE MODULAR CABLE WAS EXCHANGED AND DISCARDED. THE INFORMATION PROVIDED ALSO INDICATED THAT NO ADVERSE PATIENT CONSEQUENCES OR FUNCTIONAL ISSUES WITH THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) WERE REPORTED IN ASSOCIATION WITH THE EVENT. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD FOR MODULAR CABLE, LOT NUMBER 8172246, WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU, REV. G, AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. G, ARE CURRENTLY AVAILABLE. SECTION 2 OF THE IFU, "SYSTEM OPERATIONS" (UNDER "REPLACING THE MODULAR CABLE"), PROVIDES INSTRUCTIONS ON HOW TO REPLACE THE MODULAR CABLE. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS AND URGES PATIENTS TO INFORM THEIR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". SECTION 8 OF THE IFU, ¿EQUIPMENT STORAGE AND CARE¿, STATES: "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." SECTION 4 OF THE PATIENT HANDBOOK, ¿LIVING WITH THE HEARTMATE III¿, CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED. THIS SECTION INSTRUCTS THE USER TO ¿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.¿ IN ADDITION, SECTION 5 "ALARMS AND TROUBLESHOOTING" CONTAINS A SUB-SECTION ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES". 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. SECTION E1: REPORTER POSTAL OFFICE OR ZIP CODE: (B)(6).

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE THERE WERE NO ALARMS FOR THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE DAMAGE TO THE OUTER LAYER OF THE MODULAR CABLE. THE MODULAR CABLE WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477074 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 8172246 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male