BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4201054 · Received October 27, 2014

    Report

    Report Number
    3007042319-2014-01133
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    August 11, 2014
    Report Date
    October 14, 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 HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. A CONTROLLER AND SIX BATTERIES WERE RETURNED FOR INVESTIGATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED SCREEN BATTERIES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE DEVICES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. ANALYSIS OF THE DEVICES REVEALED THAT THE CONTROLLERS AND SCREENED BATTERIES MET SPECIFICATIONS. AN EVALUATION OF RETURNED BATTERIES (B)(4) WAS NOT PERFORMED AS THESE BATTERIES PERTAIN TO THE RECALL FSCA APR2014.1; THEREFORE PRODUCT EVALUATION IS NOT REQUIRED. THE RETURNED BATTERIES (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING IN A LAB ENVIRONMENT. THE RETURNED CONTROLLER (B)(4) PASSED VISUAL AND FUNCTIONAL TESTING. SYSTEM TESTING DID NOT INDICATE ANY ABNORMAL OPERATION OF THE CONTROLLER. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED MULTIPLE POWER SWITCHING EVENTS. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH POWER SWITCHING OF SCREENED BATTERIES ARE MOST OFTEN ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERY. POWER SWITCHING EVENTS INVOLVING UNSCREENED BATTERIES ARE MOST OFTEN ATTRIBUTED TO A FAULTY CELL. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THERE ARE NO KNOWN CLINICAL OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED 'POWER SWITCHING' EVENT IS A COMBINATION OF BATTERIES WITH FAULTY CELLS AND A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF SEVEN REPORTS (3007042319-2014-01133 AND 3007042319-2015-1282, 1311, 1294, 1295, 1310, 1312) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. 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 THEY ARE CURRENTLY USING. 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

    ADDITIONAL INFORMATION: THE BATTERIES AND CONTROLLER WERE RETURNED TO HEARTWARE ON (B)(4) 2014. HVAD: 1103, SERIAL NUMBER: (B)(4), SERIAL NUMBER: (B)(4), SERIAL NUMBER: (B)(4), SERIAL NUMBER: (B)(4). (B)(4). (B)(4): THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING IN A LAB ENVIRONMENT. DURING TESTING, NONE OF THE BATTERY CELL PAIRS EXHIBITED VOLTAGES BELOW THE 2.8 VOLTS LEVEL, AND THE FULL CHARGE CAPACITY REMAINED ABOVE 2800 MAH. REVIEW OF THE DATA LOG FILES GRAPHICALLY REVEALS A SERIES OF PREMATURE SWITCHING EVENTS BEFORE THE 25% THRESHOLD. HOWEVER THE REPORTED EVENT COULD NOT BE DUPLICATED AT BENCH LEVEL. (B)(4): THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING IN A LAB ENVIRONMENT. DURING TESTING, NONE OF THE BATTERY CELL PAIRS EXHIBITED VOLTAGES BELOW THE 2.8 VOLTS LEVEL, AND THE FULL CHARGE CAPACITY REMAINED ABOVE 2800 MAH. REVIEW OF THE DATA LOG FILES GRAPHICALLY REVEALS A SERIES OF PREMATURE SWITCHING EVENTS BEFORE THE 25% THRESHOLD. HOWEVER THE REPORTED EVENT COULD NOT BE DUPLICATED AT BENCH LEVEL. (B)(4): THE CONTROLLER PASSES VISUAL AND FUNCTIONAL TESTING. SYSTEM TESTING DID NOT INDICATE ANY ABNORMAL OPERATION OF THE CONTROLLER. REVIEW OF THE DATA LOG FILES GRAPHICALLY REVEALS A SERIES OF PREMATURE SWITCHING EVENTS BEFORE THE 25% THRESHOLD. HOWEVER THE REPORTED EVENT COULD NOT BE DUPLICATED AT BENCH LEVEL. DHR REVIEW RESULTS: A REVIEW OF THE DEVICE'S INCOMING INSPECTION RECORDS INDICATED THERE WERE NO NCMRS GENERATED THAT COULD BE ATTRIBUTED TO THE REPORTED EVENT. A DEVIATION NOTICE WAS DOCUMENTED BUT DID NOT TO CONTRIBUTE TO THE REPORTED EVENT. UPON COMPLETION OF THE REVIEW, IT WAS CONCLUDED THAT THE UNIT MET ALL THE INTERNAL REQUIREMENTS PRIOR TO THEIR QA RELEASE PROCESS. MOREOVER, THERE IS NO EVIDENCE THAT THE MANUFACTURING PROCESS WAS A CONTRIBUTORY FACTOR TO THE EVENTS REPORTED UNDER THIS COMPLAINT. SERVICING HISTORY REVIEW RESULTS: A REVIEW OF THE COMPLAINT DATA WAS COMPLETED FOR THIS PATIENT. THREE RELATED COMPLAINTS WERE FOUND. THERE IS NO RECORD OF PREVIOUS SERVICING FOR THIS PATIENT.

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. HOWEVER, THE CONTROLLER ((B)(4)) AND THE BATTERIES ((B)(4)) 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.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS, TWO MONTHS AND TWO WEEKS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PREMATURE SWITCHING FROM ONE PORT OF THE CONTROLLER TO THE OTHER. ALL THE BATTERIES AND THE CONTROLLER WERE REPLACED AND ARE BEING RETURNED TO HEARTWARE FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682359 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

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