BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4132889 · Received October 1, 2014

    Report

    Report Number
    3007042319-2014-01039
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 1, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1813-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. SITE REPORTED THAT PATIENT EXPERIENCED POWER MANAGEMENT ISSUES WITH THE EQUIPMENT. A CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE FOUR BATTERIES ASSOCIATED WITH THIS COMPLAINT WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY RELATED TO THIS EVENT. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED CONTROLLER. THOROUGH EXTERNAL VISUAL INSPECTION OF THE CONTROLLER REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED MULTIPLE "CRITICAL BATTERY" ALARMS. BATTERIES (B)(4) WERE MANUFACTURED PRIOR TO ADDITIONAL SCREENING PROCEDURES AND ARE MORE LIKELY TO EXHIBIT PREMATURE OR UNRECOGNIZED DETERIORATION OF BATTERY CAPACITY DUE TO FAULTY CELL PAIRS. ANALYSIS OF (B)(4) REVEALED THAT THE DEVICE MET SPECIFICATIONS. THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. HOWEVER, LOG FILES REVEALED THE DEVICE WAS INVOLVED IN POWER SWITCHING EVENTS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED "CRITICAL BATTERY ALARM" EVENT CAN BE ATTRIBUTED TO A COMBINATION OF BATTERIES WITH FAULTY CELLS AND A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. Z-1607-2014. 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. Z-1607-2014. 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 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. DEVICE EVALUATION ((B)(4) WERE NOT RETURNED). BATTERY - (B)(4) -1650DE- EXPIRY DATE: NONE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED CONTROLLER WAS EVALUATED BY THE MANUFACTURER AND FUNCTIONED AS EXPECTED ON BENCH. THE LOGS CRITICAL BATTERY 2 ALARMS DUE TO LOW (0%) CAPACITY; HOWEVER, THESE ALARMS WERE NOT REPRODUCED DURING BENCH TESTING THE RETURNED DEVICE. THIS EVENT IS A KNOWN MALFUNCTION WHICH IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND COVERED BY A CAPA. THIS DEVICE IS USED FOR TREATMENT AND 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, INCLUDING TRANSPORTATION.

    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.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AND FIVE DAYS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISSUES WITH CONTROLLER AND POWER SOURCES THAT INCLUDED ABNORMAL SWITCHING BETWEEN POWER SOURCES, RAPID BATTERY DEPLETION AND FAILURE TO ALTERNATE POWER SOURCES WHEN EXPECTED RESULTING IN A HIGH PRIORITY ALARM. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT; THE ISSUE WAS RESOLVED WITH REPLACEMENT OF BATTERIES AND CONTROLLER. INVESTIGATION IS ONGOING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612318 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

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