BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3854299 · Received June 6, 2014

    Report

    Report Number
    3007042319-2014-00582
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    August 13, 2013
    Report Date
    May 7, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. (B)(4) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE CONTROLLER REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE CONTROLLER PASSED VISUAL AND FUNCTIONAL TESTING. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED MULTIPLE "CONTROLLER FAULT" ALARMS ON AND NEAR THE DATE OF THE REPORTED EVENT. FURTHER ANALYSIS REVEALED THE CONTROLLER FAULT ALARM AS TYPE "SYS_UIC_APS_FAILURE"; CONTROLLER FAULT ALARMS OF THIS TYPE ARE CAUSED BY A LEAKY DIODE AND ARE HIGHLY INTERMITTENT. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS A FAULTY DIODE. ON APRIL 30, 2014, A FIELD SAFETY NOTICE (FSCA APR2014) WAS ISSUED TO US PHYSICIANS TOGETHER WITH A PATIENT LETTER TO BE DELIVERED BY SITES TO PATIENTS CURRENTLY ON DEVICE. THE FIELD SAFETY NOTICE AND PATIENT LETTER WERE INTENDED TO ENABLE PATIENTS TO RECOGNIZE ABNORMALLY BEHAVING BATTERIES AND TO SPECIFY ACTIONS TO TAKE WHEN A BATTERY NEEDS TO BE REPLACED. THE COMMUNICATIONS OUTLINED GENERAL POWER MANAGEMENT REQUIREMENTS AND FOCUSED ON RECOGNIZING THE ALARMS AND MESSAGE DISPLAYS RELATED TO THE SPECIFIC FAILURE MODES. BOXED INSTRUCTIONS WERE PROVIDED IN THE FIELD SAFETY NOTICE TO PROVIDE ADVICE TO PATIENTS AND SITES ON HOW TO RESPOND IN THE EVENT OF PREMATURE BATTERY SWITCHING, RAPID CAPACITY CHANGE, OR RAPID SWITCHING BACK AND FORTH. ADDITIONALLY, FSCA APR2015A WAS ISSUED AS A VOLUNTARY "URGENT MEDICAL DEVICE CORRECTION"; COMMUNICATION WAS ISSUED TO THE SITES AND PATIENTS WITHIN THE UNITED STATES ON MAY 11, 2015. AN "URGENT FIELD SAFETY NOTICE" WAS SENT TO SITES AND PATIENTS NOT WITHIN THE UNITED STATES ON MAY 14, 2015. 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. 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. 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.

    Additional Manufacturer Narrative · 1

    THE BATTERIES WERE RETURNED; 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 BATTERIES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. FUNCTIONAL TESTING REVEALED THAT THE RETURNED BATTERIES CONTAINED A FAULTY CELL PAIR,WHICH MOST LIKELY CONTRIBUTED TO THE REPORTED EVENT. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE. THIS EVENT RELATES TO THE FSCA (B)(4) ISSUED BY HEARTWARE, INC. FOR THIS MATTER. THIS IS ONE OF TWO REPORTS (3007042319-2014-00582, AND 583) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY THREE MONTHS POST HVAD IMPLANTATION ,THE SITE REPORTED THAT THE PATIENT'S BATTERIES WERE NOT HOLDING CHARGE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332861 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BAT093032- BATTERY