BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 10522225 · Received September 11, 2020

    Report

    Report Number
    2916596-2020-04253
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 13, 2020
    Report Date
    December 2, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF THE RETURNED MODULAR CABLE CONFIRMED SUPERFICIAL DAMAGE TO THE OUTER POLYURETHANE JACKET. UPON EXAMINATION OF THE MODULAR CABLE, THE CONTROLLER AND INLINE CONNECTOR BEND RELIEFS REVEALED GRAY DISCOLORATION. THE RESCUE TAPE WAS REMOVED AND REVEALED COSMETIC DAMAGE TO THE POLYURETHANE JACKET ADJACENT TO THE CONTROLLER CONNECTOR. THE POLYURETHANE JACKET WAS CRACKED AND TORN APPROXIMATELY 4.5¿ FROM THE CONTROLLER CONNECTOR AND WAS FOLDING OVER ITSELF; HOWEVER, THE DAMAGE TO THE POLYURETHANE JACKET DID NOT APPEAR TO PENETRATE THE UNDERLYING ARMOR LAYER, WHICH WAS UNREMARKABLE. ADDITIONALLY, SUPERFICIAL DAMAGE AND CRACKING WAS NOTED 20.5¿ FROM CONTROLLER CONNECTOR. THE CLEAR BIONATE LAYER WAS ALSO UNREMARKABLE. THE UNDERLYING WIRES SHOWED KINKING APPROXIMATELY 10¿ FROM THE CONTROLLER CONNECTOR; HOWEVER, THERE WAS NO DAMAGE TO INTERNAL CONDUCTORS OR WIRE INSULATION. THE MODULAR CABLE WAS CONNECTED TO A CIRRIS TESTER TO EVALUATE THE INTEGRITY OF ITS WIRES. THE CABLE PASSED ELECTRICAL TESTING WITHOUT ISSUE. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT NUMBER 200118, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MODULAR CABLE WAS SHIPPED ON UNDER ORDER. THE CURRENT VERSION OF THE HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK CONTAIN INFORMATION ON CARING FOR THE DRIVELINE. SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ IN THE IFU STATES THAT A DAMP CLOTH CAN BE USED TO CLEAN EXTERIOR SURFACES OF THE EXTERNAL PARTS OF THE EQUIPMENT. WATER, WITH OR WITHOUT A MILD DISH SOAP, MAY BE USED AS A SURFACE CLEANER. SECTION 8 ALSO WARNS THAT PATIENTS SHOULD NEVER SUBMERGE THE DRIVELINE IN WATER OR LIQUID. SECTION 6 ¿CARING FOR THE EQUIPMENT¿ IN THE PATIENT HANDBOOK ALSO OUTLINES PROPER DRIVELINE MAINTENANCE FOR THE PATIENT. THE USER SHOULD CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS) AND CALL THEIR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SILICONE WAS CRACKED AND THERE WERE WIRES VISIBLE IN THE MODULAR CABLE. THE MODULAR CABLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986536 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525 6252688

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR