BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4063193 · Received September 5, 2014

    Report

    Report Number
    3007042319-2014-00931
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    July 26, 2014
    Report Date
    August 8, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE AVAILABLE FOR EVALUATION, BUT HAVE NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VENTRICULAR ASSIST DEVICE (VAD) IS USED FOR TREATMENT NOT DIAGNOSIS. THE DEVICES RELATED TO THE REPORTED EVENT WERE EXCHANGED WITHOUT INCIDENT AND THERE WAS NO REPORTED PATIENT INJURY. A CONTROLLER AND FIVE BATTERIES WERE RETURNED TO HEARTWARE FOR EVALUATION. 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 DEVICES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. THE CONTROLLER AND BATTERIES ((B)(4)) PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING; THE ANALYZED DEVICES PERFORMED PER SPECIFICATION UNDER TESTING CONDITIONS AND WERE UNABLE TO DUPLICATE THE REPORTED EVENT AT BENCH LEVEL. THE REPORTED EVENT WAS CONFIRMED, AS THESE BATTERIES WERE CONFIRMED TO BE INVOLVED IN PREMATURE POWER SWITCHING EVENTS LIKELY AS A RESULT OF A COMMUNICATION ERROR. ANALYSIS OF THE BATTERY ((B)(4)) REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS; THE BATTERY FAILED FUNCTIONAL TESTING DUE TO A DEFECTIVE U2 CHIP ON THE PRINTED CIRCUIT ASSEMBLY. THIS TYPE OF MALFUNCTION IS CURRENTLY BEING INVESTIGATED UNDER AN INTERNAL INVESTIGATION WHICH HAS IDENTIFIED THIS ISSUE TO BE RELATED TO A COMMUNICATION ERROR THAT CAN POTENTIALLY CAUSE POWER SWITCHING. A VOLUNTARY FIELD CORRECTION, FSCA APR2014, WAS INITIATED ON APRIL 30, 2014 REGARDING ALL HEARTWARE® VENTRICULAR ASSIST SYSTEM BATTERIES, PRODUCT CODES 1650 AND 1650-DE. THE FIELD CORRECTION PROVIDED PATIENTS AND HEALTHCARE PROVIDERS WITH INFORMATION TO RECOGNIZE BATTERIES WITH LESS THAN TWO HOURS OF RUN TIME, REEMPHASIZE INSTRUCTION ON ACTIONS TO TAKE WHEN BATTERY ALARMS OCCUR AND REINFORCE PROPER POWER MANAGEMENT. LABELING LANGUAGE ALSO WILL BE CLARIFIED TO ALIGN WITH THE INFORMATION CONTAINED IN THE FSCA APR2014 CORRECTION NOTICE. HEARTWARE LATER EXPANDED THE VOLUNTARY FIELD ACTION, FSCA APR2014.1, FOR THE REMOVAL OF UNSCREENED BATTERIES ((B)(4)) FROM THE FIELD. 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 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 FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS IS ONE OF SIX REPORTS (3007042319-2014-00931, 2015-01422, 2015-01423, 2015-01424, 2015-01425 AND 2015-01426) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT ONE YEAR AND 5 MONTHS POST HEARTWARE LVAD IMPLANTATION WHO EXPERIENCED A CHANGE OF POWER SOURCE IN THE CONTROLLER EARLIER THAN EXPECTED AND PUMP STOP. THE BATTERIES AND CONTROLLER WERE REMOVED FROM THE PATIENT AND A NEW SET WAS 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
    544519 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY- (B)(4)| BATTERY- (B)(4)| BATTERY- (B)(4)| BATTERY- (B)(4)| BATTERY - (B)(4)