BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4143445 · Received October 6, 2014

    Report

    Report Number
    3007042319-2014-01060
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    January 13, 2014
    Report Date
    September 8, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE CONTROLLER REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION; FUNCTIONAL TESTING REVEALED THAT THE DEVICE PERFORMED PER SPECIFICATIONS. THE EVENT COULD NOT BE REPRODUCED IN THE LAB AND NO EVIDENCE WAS FOUND IN THE LOG FILES. HOWEVER, LOG FILES DID REVEAL A LOSS OF POWER, WHICH RESULTS IN A CONTINUOUS HIGH PRIORITY ALARM, WHILE THE CONTROLLER WAS CONNECTED TO AN OLDER (UNSCREENED) BATTERY. THERE ARE NO KNOWN CLINICAL OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; LOSS OF POWER EVENTS MAY BE DUE TO A FAULTY POWER SOURCE, HOWEVER, THE MOST LIKELY ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. 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. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A BACK-UP CONTROLLER AVAILABLE AT ALL TIMES, BEYOND THE PRIMARY CONTROLLER THAT IS CURRENTLY IN USE. PATIENTS ARE INSTRUCTED TO CONTACT THE TREATING FACILITY IF THEY RECEIVE ANY OF A LIST OF CERTAIN ALARMS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER (B)(4), DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY 14 MONTHS AFTER HVAD® IMPLANTATION, IT WAS REPORTED THAT THAT PATIENT EXPERIENCED A RED BATTERY ALARM WITH A FULLY CHARGED BATTERY. PATIENT NOTED THIS OCCURRED A COUPLE OF TIMES WITH VARIOUS POWER SOURCES. THE CONTROLLER WAS EXCHANGED WITHOUT ANY REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622887 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROLLER - (B)(4)