BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4933197 · Received July 22, 2015

    Report

    Report Number
    3007042319-2015-01570
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    February 16, 2015
    Report Date
    February 16, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A SPARE SET OF FULLY CHARGED BATTERIES AVAILABLE AT ALL TIMES, BEYOND THE TWO (2) POWER SOURCES THAT ARE CURRENTLY CONNECTED TO THE CONTROLLER. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS A BLANK, UNKNOWN AND AS NO INFORMATION (NI); THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS MEDICAL DEVICE REPORT WAS NOT SUBMITTED TO THE FDA WITHIN THE TIMEFRAME AS REQUIRED BY 21 CFR PART 803- MEDICAL DEVICE REPORTING. THIS ERROR WAS DISCOVERED DURING REVIEW OF COMPLAINT FILES PER HEARTWARE (B)(4), CORPORATE QUALITY PLAN- COMPLAINT MANAGEMENT PROCESS, AND ROUTINE COMPLAINT FILE INVESTIGATION ACTIVITIES.

    Additional Manufacturer Narrative · 1

    BATTERY (B)(4) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE BATTERY IN RELATION TO THE REPORTED EVENT. HOWEVER, THE PROBLEM COULD NOT BE REPLICATED IN BENCH TESTING. ANALYSIS OF THE BATTERY REVEALED THAT IT MET SPECIFICATIONS; IT PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILES WERE NOT AVAILABLE FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED; THE BATTERY PASSED TESTING. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. 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

    IT WAS REPORTED THAT THE BATTERY GIVES A POWER SWITCH ON THE CONTROLLER ALTHOUGH THE CHARGE WERE OVER 25%. IT WAS REPORTED THAT THERE WAS NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475893 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR