BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4042124 · Received August 27, 2014

    Report

    Report Number
    3007042319-2014-00909
    Event Type
    Death
    Date Received
    August 27, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VENTRICULAR ASSIST DEVICE (VAD) IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND EMERGENTLY PLACED ON ECMO AFTER THE PATIENT CUT THROUGH THEIR DRIVELINE CABLE WITH SCISSORS CAUSING THE VAD TO STOP. A HEARTWARE CLINICAL ENGINEER REPAIRED THE DRIVELINE CABLE; THE PUMP RESTARTED BUT THE PATIENT EXPIRED THE FOLLOWING DAY. IT WAS REPORTED THAT THE DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE DEVICES MET ALL REQUIREMENTS FOR RELEASE. CONSIDERING THAT THIS FAILURE MODE WILL OCCUR ONLY IF THE EVENT IS INDUCED BY THE USER (ACCIDENT OR TRAUMA), THE MOST EFFECTIVE MITIGATION IS PREVENTION. THE HEARTWARE SYSTEM INSTRUCTIONS FOR USE (IFU), PATIENT MANUAL, AND TRAINING MATERIAL PROVIDE CLEAR INSTRUCTIONS TO THE USER ON PROPER USAGE AND CARE OF THE DRIVELINE CABLE. A HEARTWARE CLINICAL ENGINEER PERFORMED A VISUAL EXAMINATION CONFIRMING THAT THE DRIVELINE CABLE HAD BEEN COMPLETELY SEVERED AND PROCEEDED TO PERFORM A "DRIVELINE SPLICE REPAIR' PROCEDURE TO REMEDIATE THE SEVERED DRIVELINE CABLE. THE PROCEDURE SUCCESSFULLY RESTARTED THE PUMP. THE ACTUAL ROOT CAUSE OF THE REPORTED EVENT IS USER ERROR WHEREIN THE PATIENT SEVERED THE DRIVELINE CABLE. THIS RESULTED IN A PUMP STOP AND MEDICAL COMPLICATIONS THAT MAY HAVE LED TO THE SUBSEQUENT DEATH. 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. THE HEARTWARE HVAD INSTRUCTIONS FOR USE ADVISES THAT THE DRIVELINE COVER SHOULD COMPLETELY COVER THE CONTROLLER'S SILVER DRIVELINE CONNECTOR TO PROTECT IT AND KEEP IT CLEAN. THE IFU INSTRUCTS, "DO NOT DISCONNECT THE DRIVELINE OR POWER SOURCES FROM THE CONTROLLER WHILE CLEANING IT OR THE PUMP WILL STOP. IF THIS HAPPENS, RECONNECT THE DRIVELINE TO THE CONTROLLER AS SOON AS POSSIBLE TO RESTART THE PUMP. THE INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES TO PROTECT THE DRIVELINE FROM DAMAGE AND WARNS THAT SHOULD THE DRIVELINE BECOME DISCONNECTED FROM THE CONTROLLER IT WILL RESULT IN A PUMP STOP. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    APPROXIMATELY TWENTY-EIGHT WEEKS POST HVAD IMPLANTATION, THE PATIENT WAS HOSPITALIZED FOR DRIVELINE (DL) WIRE DAMAGE AFTER THEY CUT THROUGH THE DL WITH SCISSORS WHILE ATTEMPTING TO REMOVE SARAN WRAP FROM THEIR ABDOMINAL DRESSING. THE PATIENT WAS EMERGENTLY PLACED ON ECMO, AND A DRIVELINE SPLICE REPAIR WAS PERFORMED. THE PUMP RESTARTED BUT THE PATIENT SUBSEQUENTLY EXPIRED. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521111 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death