BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4862152 · Received June 23, 2015

    Report

    Report Number
    3007042319-2015-01284
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 27, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. IFU STATES: ALWAYS KEEP A SPARE CONTROLLER AND FULLY CHARGED SPARE BATTERIES AVAILABLE AT ALL TIMES IN CASE OF AN EMERGENCY, BEYOND THE TWO (2) POWER SOURCES THAT ARE CURRENTLY CONNECTED TO THE CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS TWO OF THREE REPORTS (3007042319-2015-01283, 3007042319-2015-01284 AND 3007042319-2015-01285) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. CURRENT DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    UNCHECKED "USER FACILITY". LOG FILE ANALYSIS REVEALED SEVERAL OCCURRENCES OF CONTROLLER POWER-UP/MOTOR START EVENTS. THESE EVENTS INDICATE THAT BOTH POWER SUPPLIES WERE DISCONNECTED FROM THE CONTROLLER. LOG FILE ANALYSIS ALSO REVEALED OCCURRENCES OF CRITICAL BATTERY ALARMS AND PREMATURE POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS BETWEEN THE BATTERY AND THE CONTROLLER. ONE BATTERY WAS NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION FOR (B)(4) CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED SEVERAL OCCURRENCES OF CONTROLLER POWER-UP/MOTOR START EVENTS, CRITICAL BATTERY ALARMS, AND PREMATURE POWER SWITCHING EVENTS. THE DEVICE WAS RELATED TO THE REPORTED EVENT; HOWEVER THIS EVENT COULD NOT BE DUPLICATED AT THE BENCH LEVEL. THE MOST LIKELY ROOT CAUSE OF THE FAILURE IS A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND THE BATTERIES, WHICH LIKELY CONTRIBUTED TO THE EVENT. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO ADDRESS THIS ISSUE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS TWO OF THREE REPORTS (3007042319-2015-01283, 3007042319-2015-01284 AND 3007042319-2015-01285) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED 2 PUMP STOPS WITH ALARMS. THE CONTROLLER AND BATTERIES WERE EXCHANGED WITH NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405087 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR