BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 9861312 · Received March 20, 2020

    Report

    Report Number
    2916596-2020-01288
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    March 3, 2020
    Report Date
    May 19, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF COSMETIC DAMAGE TO THE DRIVELINE WAS CONFIRMED. THE SUBMITTED LOG FILE CONTAINED RELEVANT DATA FROM (B)(6) 2020 THROUGH (B)(6) 2020. A NO EXTERNAL POWER ALARM WAS CAPTURED ON (B)(6) 2020. THE SYSTEM CONTROLLER¿S INTERNAL 11V BACKUP BATTERY WAS IN USE DURING THIS EVENT AND THERE WAS NO INTERRUPTION IN PUMP SUPPORT. NO OTHER ATYPICAL ALARMS OR EVENTS WERE CAPTURED. THE ACTUAL SPEED REMAINED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILE AND THE DEVICE APPEARED TO BE FUNCTIONING AS INTENDED WITH STABLE PARAMETERS. APPROXIMATELY 13.5" OF THE DRIVELINE WAS RETURNED. A PREVIOUS DRIVELINE REPAIR WAS PRESENT AT THE PROXIMAL END OF THE RETURNED DRIVELINE SEGMENT (MFR. REPORT #2916596-2019-00074). WHITE TAPE WAS WRAPPED AROUND THE DRIVELINE APPROXIMATELY 1.0¿-4.0¿ AND 6.0¿-9.0¿ FROM THE METAL CONNECTOR. THE METAL CONNECTOR BEND RELIEF AND PINS APPEARED UNREMARKABLE. AN ELECTRICAL CONTINUITY TEST OF THE DRIVELINE WAS CONDUCTED IN THE CONDITION THE DRIVELINE WAS RETURNED AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. NO WIRE-TO-WIRE OR WIRE-TO-SHIELD SHORTS WERE INDUCED DURING THIS TESTING. UPON REMOVAL OF THE TAPE, VISUAL EXAMINATION OF THE DRIVELINE REVEALED COSMETIC DAMAGE TO THE OUTER SILICONE SLEEVE APPROXIMATELY 2.5¿ AND 8.0¿ FROM THE METAL CONNECTOR AS WELL AS COSMETIC DAMAGE TO THE OUTER GRAY SHRINK TUBING AT THE DISTAL END OF THE REPAIR. OTHER THAN THIS DAMAGE, THE SILICONE JACKET WAS UNREMARKABLE. THE CLEAR BIONATE LAYER WAS IN GOOD CONDITION AND APPEARED UNREMARKABLE. BREAKDOWN OF THE METAL BRAIDED SHIELD WAS OBSERVED IN MULTIPLE LOCATIONS. VISUAL AND MICROSCOPIC INSPECTION OF THE WIRING DID NOT REVEAL ANY AREAS OF DAMAGE ALONG THE LENGTH OF THE REPLACED DRIVELINE WHICH EXPOSED THE METAL CONDUCTORS. THE DRIVELINE WAS THEN SUBMERGED IN A SALINE SOLUTION FOR HI-POT TESTING TO CHECK FOR CURRENT LEAKAGE THROUGH THE WIRE INSULATION, AND NO AREAS OF COMPROMISED WIRE INSULATION WERE IDENTIFIED. THERE WAS ALSO AN INCIDENTAL FINDING OF MINOR WEAR OF THE GREEN DASH ALIGNMENT INDICATOR ON THE METAL CONNECTOR. HEARTMATE II LVAS IFU SECTION 6 "PATIENT CARE AND MANAGEMENT" ADDRESSES HOW TO CARE FOR THE DRIVELINE; HOWEVER, ALL HEARTMATE II DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT ON DURATION OF USE AND MOVEMENT/FLEXING OVER TIME. IN ADDITION, SECTION 6, UNDER "PUMP PERFORMANCE MONITORING", OUTLINES INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. SECTION 8 "EQUIPMENT STORAGE AND CARE" OF THE HEARTMATE II LVAS IFU AND SECTION 6 "CARING FOR THE EQUIPMENT" OF THE HEARTMATE II PATIENT HANDBOOK PROVIDE INSTRUCTIONS FOR CLEANING THE LVAS EQUIPMENT AND PROVIDE A LIST OF CLEANING AGENTS THAT CAN BE USED. HEARTMATE II LVAS PATIENT HANDBOOK SECTION 4 "LIVING WITH THE HEARTMATE II" CONTAINS A SECTION TITLED "CARING FOR THE DRIVELINE". SECTION 6 "CARING FOR THE EQUIPMENT" DISCUSSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE AND OUTLINES INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. IFU, PATIENT INSTRUCTIONS REPLACED HMII LVAD PERCUTANEOUS LEAD, PROVIDES CARE INSTRUCTIONS AND IMPORTANT PRECAUTIONS REGARDING REPLACED PERCUTANEOUS LEADS. 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 A PATIENT CAME INTO THE EMERGENCY ROOM FOLLOWING A MOTOR VEHICLE CRASH AND THEIR LOG FILES WERE SUBMITTED FOR REVIEW. LOG FILE REVIEW REVEALED A NO EXTERNAL POWER ALARM WHILE ATTACHED TO A POWER MODULE, WHICH MIGHT HAVE BEEN CAUSED BY A DOUBLE POWER CABLE DISCONNECT OR A BAD CONNECTION OF THE PATIENT CABLE TO THE POCKET CONTROLLER. THE SUBMITTED X-RAY SHOWED AN AREA OF SOME SHIELDING DAMAGE. THERE ARE NO SIGNS OF PUMP STOPS OR LOW SPEED OPERATIONS AT THIS TIME. ON (B)(6) 2020, TECHNICAL SERVICES PERFORMED COSMETIC DRIVELINE REPAIR APPROXIMATELY 2 INCHES FROM THE EXIT SITE AND THE PERCUTANEOUS LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321925 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR