BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8721837 · Received June 21, 2019

    Report

    Report Number
    2916596-2019-02654
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    June 3, 2019
    Report Date
    October 11, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONTROLLER ORIGINALLY CLOSED ON (B)(6) 2019. THE INVESTIGATION REVEALED THAT THERE WAS FLUID INGRESS ON THE MAIN PRINTED CIRCUIT BOARD. THE PUMP RUNNING SYMBOL OFF, RED HEART AND YELLOW WRENCH ALARMS WERE ORIGINALLY REPORTED AGAINST THE PUMP AND REPORTABILITY OF THE CONTROLLER WAS RECONSIDERED AFTER THE PUMP INVESTIGATION. THE PUMP INVESTIGATION DID NOT REVEAL WIRE DAMAGE BUT DID FIND DAMAGE TO THE SILICONE JACKET. THIS DAMAGE TO THE SILICONE JACKET CAN BE A SOURCE OF THE FLUID INGRESS. THEREFORE, THE CONTROLLER INVESTIGATION WAS REOPENED TO DETERMINE IF THE SOURCE OF FLUID INGRESS IN THE CONTROLLER COULD BE RELATED TO THE DAMAGED SILICONE JACKET. UPON REVIEW OF THE CONTROLLER IT APPEARED THE SOURCE OF THE FLUID INGRESS WAS THE DAMAGED SILICONE JACKET BECAUSE IT WAS FOUND FLUID ENTERED THROUGH THE DRIVELINE CONNECTOR. SECTION A2: CORRECTION. SECTION B5, D4, D11, H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED DAMAGE TO THE OUTER SILICONE JACKET OF THE PATIENT¿S DRIVELINE WAS CONFIRMED THROUGH THE ACCOUNT¿S SUBMITTED IMAGES. THE HEARTMATE II LVAS IFU AND PATIENT HANDBOOK PROVIDE INFORMATION ON HOW TO CARE FOR THE DRIVELINE AND ADDRESS DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT TOOK A SHOWER SEVERAL HOURS BEFORE THE CONTROLLER FAILURE OCCURRED. THERE WAS NO VISIBLE EVIDENCE OF FLUID UNDERNEATH THE WHITE SILICONE NOR THE CLEAR INNER POLYURETHANE JACKET. THE TEAR IN THE WHITE SILICONE SLEEVE WAS WELL COVERED WITH SELF-ADHESIVE SILICONE TAPE.

    Additional Manufacturer Narrative · 1

    THE REFERENCED SHORT-TO-SHIELD WAS REPORTED UNDER MFR. REPORT # 2916596-2018-00097. APPROXIMATE AGE OF DEVICE- 4 YEARS, 1 MONTH. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT THE PUMP RUNNING SYMBOL WAS OFF AND THE RED HEART AND YELLOW WRENCH WERE DIMLY ILLUMINATED WITH A BLANK SCREEN IN ADDITION TO A CONTINUOUS ALARM. THE PATIENT HAS HAD A SPLICE IN THE PAST FOR A SHORT-TO-SHIELD AND HAS EXPERIENCED A FEW PUMP STOPS ON A GROUNDED CABLE SINCE THEN. THIS IS THE FIRST EVIDENCE OF PUMP STOPS THAT OCCURRED ON AN UNGROUNDED CABLE. THERE WAS DAMAGE TO THE DRIVELINE IN THE FORM OF A TEAR IN THE OUTER SHEATH ADJACENT TO THE SPLICE AND PROXIMAL TO THE PUMP THAT WAS WELL COVERED WITH SELF-ADHESIVE SILICONE TAPE. THE SPLICE ON THE DRIVELINE IS 12 INCHES FROM THE DRESSING. THERE WAS NO VISIBLE EVIDENCE OF FLUID UNDERNEATH THE WHITE SILICONE NOR THE CLEAR INNER POLYURETHANE JACKET. LOG FILE ANALYSIS DID NOT OBSERVE ANY EVIDENCE OF A PERCUTANEOUS LEAD ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514503 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HEARTMATE II SYSTEM CONTROLLER