BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3855179 · Received June 9, 2014

    Report

    Report Number
    3007042319-2014-00598
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 9, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT PATIENT EXPERIENCED AN AUDIBLE ALARM ON THE CONTROLLER ON THE EVENT DATE. THE PATIENT REPORTED TO THE SITE AND A POWER DISCONNECT WAS LOGGED ON THE MONITOR TWO DAYS AFTER REPORTED EVENT DATE. ALL THE BATTERIES WERE REPLACED. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. THE BATTERY ((B)(4)) WAS NO RETURNED FOR EVALUATION DESPITE MULTIPLE ATTEMPTS TO OBTAIN IT. A REVIEW OF THE CONTROLLER LOG FILES INDICATED A LOSS OF POWER EVENT AND AN ALARM INDICATING A POWER DISCONNECT EVENT; HOWEVER THE CODE ASSOCIATED WITH THE ALARM IS NOT INDICATIVE OF BATTERY MALFUNCTIONING. THE ROOT CAUSE OF THE REPORTED "ALARMS/FAULTS" EVENT CANNOT BE CONCLUSIVELY DETERMINED. FIELD SAFETY NOTICE (FSCA APR2014) WAS ISSUED TO PROVIDE PATIENTS AND HEALTHCARE PROVIDERS WITH INFORMATION TO RECOGNIZE BATTERIES WITH LESS THAN TWO HOURS OF RUN TIME, AS WELL AS REEMPHASIZE INSTRUCTION ON ACTIONS TO TAKE WHEN BATTERY ALARMS OCCUR AND REINFORCE PROPER POWER MANAGEMENT. FIELD SAFETY NOTICE WAS THEN EXPANDED (FSCA APR2014.1) IN ORDER TO REMOVE BATTERIES FROM THE FIELD THAT WERE RELEASED PRIOR TO THE IMPLEMENTATION OF ENHANCED BATTERY SCREENING PROCESS TO ADDRESS AND PREVENT BATTERY FAILURES. 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 INSTRUCTIONS FOR USE (IFU), PATIENT MANUAL, AND TRAINING MATERIAL PROVIDE CLEAR INSTRUCTIONS TO THE USER ON PROPER USAGE AND CARE OF POWER SOURCES. THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, VISUAL AND AUDIBLE ALARM MANAGEMENT, AND DEVICE MANAGEMENT; ADDITIONAL GUIDELINES INSTRUCT THE USER ON HOW TO DETECT AND REACT TO A POWER SOURCE MALFUNCTION. 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. 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 FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS IS TWO OF TWO REPORTS (3007042319-2014-00597 AND 3007042319-2014-00598) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTS (3007042319-2014-00597 AND 3007042319-2014-00598) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. NOT YET RECEIVED.

    Description of Event or Problem · 1

    APPROXIMATELY FOUR MONTHS POST HVAD IMPLANTATION, THE PATIENT EXPERIENCED A POWER DISCONNECT. THE BATTERIES WERE REMOVED FROM THE PATIENT AND NEW BATTERIES WERE SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. A PRELIMINARY REVIEW OF THE CONTROLLER LOG FILES REVEALED A LOSS OF POWER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334702 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1