BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 3999372 · Received August 11, 2014

    Report

    Report Number
    3007042319-2014-00823
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    February 6, 2014
    Report Date
    July 17, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS RETURNED; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE BATTERY IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE BATTERY REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. FUNCTIONAL TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL PAIR. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND EVALUATION STILL ONGOING. PRELIMINARY EVALUATION AND TESTING OF THE RETURNED BATTERY REVEALED AN INTERNAL FAULTY CELL. THIS FINDING WAS RE-ASSESSED PER OUR SOP REQUIREMENTS, AND DETERMINED TO BE REPORTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. 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 DEVICE REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. ANALYSIS OF (B)(4) REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE BATTERY AS RECEIVED WAS INOPERABLE; THE BATTERY PACK FIRMWARE HAD MULTIPLE FLAGS PUV AND CUV ENABLED. HOWEVER, AFTER RECHARGING THE BATTERY PACK, MACCOR TESTING WAS CONDUCTED. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A BATTERY WITH 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. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE. FOLLOWING ADDITIONAL REGULATORY AUTHORITY FEEDBACK, THE MANUFACTURER HAS EXPANDED THE FIELD SAFETY CORRECTIVE ACTION (FSCA) TO RECALL CERTAIN OLDER BATTERIES (REFERENCED UNDER FILE NAME: FSCA APR2014.1). THE EXPANSION OF THIS FSCA IS TO REMOVE CERTAIN OLDER BATTERIES WHICH WERE PRODUCED IN SPECIFIC RANGES OF BATTERY SERIAL NUMBERS WHICH ARE MORE LIKELY TO EXHIBIT PREMATURE OR UNRECOGNIZED DETERIORATION OF BATTERY CAPACITY. OUR RISK ASSESSMENT FOR THIS ISSUE REMAINS UNCHANGED AT THIS TIME. COMPLAINTS WILL CONTINUE TO BE CLOSELY MONITORED TO ENSURE THAT THE VENTRICULAR ASSIST DEVICE SYSTEM FUNCTIONS AS INTENDED AND TO ASSESS THE EFFECTIVENESS OF THE FSN FOR ADDITIONAL ACTIONS. THIS DEVICE IS USED FOR TREATMENT 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. 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. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO 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.

    Description of Event or Problem · 1

    APPROXIMATELY 05 MONTHS AFTER HEARTWARE LVAD IMPLANTATION, THE SITE REPORTED AN EVENT INVOLVING A PATIENT WHOS BATTERY WAS NOT CHARGING. THE BATTERY WAS REPLACED WITH ONE FROM THE HOSPITAL'S STOCK, AND THE UNIT IN QUESTION WAS RETURNED TO HEARTWARE FOR ANALYSIS. NO HARM OR INJURY TO PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476760 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1