BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 3195428 · Received June 28, 2013

    Report

    Report Number
    3007042319-2013-00107
    Event Type
    Death
    Date Received
    June 28, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 31, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT INDICATES AN ISSUE WITH THE PERFORMANCE OF A PATIENT PACK AND THE CONNECTOR OF THE DRIVELINE CABLE. THE PATIENT'S EXPLANTED PUMP AND PATIENT PACK WERE RETURNED TO HEARTWARE FOR EVALUATION. THE CONTROLLER WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE PUMP AND CONTROLLER MET ALL REQUIREMENTS FOR RELEASE. THE PUMP ((B)(4)) UNDERWENT AN INDEPENDENT PATHOLOGICAL ANALYSIS; ANALYSIS CONFIRMED THAT THERE WERE NO CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. VISUAL EVALUATION OF INDEPENDENTLY PROVIDED PHOTOS OF THE PATIENT PACK REVEALED THAT THE SHOULDER HARNESS STRAP WAS DISCONNECTED FROM THE MAIN BODY OF THE PATIENT PACK. THE CAUSE OF THIS DAMAGE CANNOT BE CONCLUSIVELY DETERMINED. THE CONFIRMED DEVICE MALFUNCTION IS RELATED TO THE REPORTED EVENT. THE IFU INSTRUCTS THE USER ON PROPER USAGE OF THE PATIENT PACK. IN ADDITION, THE IFU PROVIDES GUIDELINES TO HELP THE USER TO DETECT AND REACT TO AN HVAD PUMP STOP. THE PATIENT PACK HAS AN ADDITIONAL WAIST STRAP AS A SAFETY REDUNDANCY; IN THIS CASE ONLY THE SHOULDER HARNESS STRAP WAS AFFECTED. MOREOVER, HEARTWARE CLINICAL OPERATOR TRAINING FURTHER EDUCATES HEALTHCARE PRACTITIONERS ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND HVAD SUPPORT. REVIEW OF THE CONTROLLER LOG FILES REVEALED MULTIPLE VAD STOPPED/VAD DISCONNECT ALARMS AT THE TIME OF THE EVENT. WHEN THE PATIENT PACK WAS DROPPED, THE TENSILE FORCE EXPERIENCED BY THE CONTROLLER CAUSED THE DRIVELINE TO BECOME DISCONNECTED FROM THE CONTROLLER, CAUSING THE PUMP TO STOP. WHILE THE DRIVELINE WAS DISCONNECTED, IT APPEARS THAT THE LARGE AMOUNT OF TAPE APPLIED DURING A DRIVELINE SELF-REPAIR PREVENTED THE PATIENT FROM SLIDING THE DRIVELINE BOOT AND RECONNECTING THE DRIVELINE TO THE CONTROLLER. WHEN THE TAPE WAS REMOVED, THE CARE PROVIDERS WERE ABLE TO RECONNECT THE DRIVELINE TO THE CONTROLLER AND THE PUMP STARTED WITH NO EVIDENCE OF FAULTS. SUBSEQUENTLY, A HEARTWARE CLINICAL ENGINEER PERFORMED A DRIVELINE SHEATH REPAIR PROCEDURE TO REMEDIATE THE INDEPENDENT REPAIR. THE MOST LIKELY ROOT CAUSE OF THE INABILITY TO RECONNECT THE DRIVELINE TO THE CONTROLLER IS TAPE APPLIED DURING A DRIVELINE SELF-REPAIR PREVENTING THE PATIENT FROM BEING ABLE TO SLIDE THE DRIVELINE BOOT AND RECONNECT THE DRIVELINE TO THE CONTROLLER. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS, INCLUDING TRANSPORTATION. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT DURING HOSPITALIZATION FOR THIS EVENT THE PATIENT HAD DEVELOPED LEUKOCYTOSIS TREATED WITH BROAD SPECTRUM ANTIBIOTICS AND REQUIRED CONTINUAL RENAL REPLACEMENT THERAPY (CRRT) FOR RENAL FAILURE MOST LIKELY THE RESULT OF ISCHEMIC TUBULAR NECROSIS WITH OLIGURIA. REVIEW OF LOG FILES REVEALED MULTIPLE "VAD STOPPED/VAD DISCONNECT" ALARMS AT THE TIME OF THE EVENT WITH A PUMP OFF TIME OF FORTY-SEVEN MINUTES. THE DEVICE HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY FORTY-THREE MONTHS AFTER LVAD IMPLANTATION, THE PATIENT HAD BEEN AT HOME COOKING WHEN HER CARRYING CASE STRAP BROKE AND FELL TO THE FLOOR WITH THE CONTROLLER INSIDE. THE DRIVELINE OF THE PUMP ((B)(4)) BECAME DISCONNECTED FROM THE CONTROLLER. FAMILY MEMBERS, UNABLE TO RE-CONNECT HER DRIVELINE TO THE CONTROLLER, CALLED EMERGENCY RESPONSE. THE PARAMEDIC¿S ARRIVED AND CARDIO-PULMONARY RESUSCITATION (CPR) WAS INITIATED. THE EMERGENCY RESPONSE PERSONNEL WERE UNABLE TO RE-CONNECT HER DRIVELINE TO THE CONTROLLER AND SHE WAS TRANSPORTED TO A LOCAL HOSPITAL. THE (ER) PHYSICIAN REPORTED THAT THE DRIVELINE BOOT COULD NOT BE MOVED BECAUSE THE PATIENT HAD PERFORMED A SELF-REPAIR AND APPLIED HER OWN RESCUE TAPE NEAR THE DRIVELINE STRAIN RELIEF WHICH WAS PREVENTING THE BOOT FROM SLIDING DOWN THE DRIVELINE AS DESIGNED. A CONTROLLER EXCHANGE WAS PERFORMED AND THE PUMP RE-STARTED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR HYPOTHERMIC THERAPY, BUT HER CONDITION NECESSITATED INTUBATION, MECHANICAL VENTILATION AND SEDATION. ONCE IN THE ICU, THE PATIENT¿S TAPE WAS REMOVED FROM THE DRIVELINE AND A SHEATH REPAIR WAS PERFORMED OVER THE DAMAGED AREA BY HEARTWARE ENGINEER. ELEVEN DAYS AFTER THE INITIAL ONSET OF THIS EVENT, THE FAMILY WITHDREW CARE AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297039 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L CONTROLLER (UNK SERIAL NUMBER)