BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5754683 · Received June 28, 2016

    Report

    Report Number
    3007042319-2016-02410
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 8, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1917-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER IN ORDER TO PREVENT DAMAGES. ADDITIONALLY, A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE AND THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIMES. IT ALSO PROVIDES INFORMATION ABOUT PROPER CARE OF THE SYSTEM AND WHAT TO DO IN CASE OF AN EMERGENCY. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: BATTERY: (B)(4) - EXPIRATION DATE: 04-30-20216, BATTERY: (B)(4) - EXPIRATION DATE: 05-31-20216, BATTERY: (B)(4) - EXPIRATION DATE: 01-31-20216, BATTERY: (B)(4) - EXPIRATION DATE: 04-30-20216, BATTERY: (B)(4) - EXPIRATION DATE: 04-30-20216. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED CRITICAL BATTERY ALARMS AND PREMATURE SWITCHING EVENTS WERE CONFIRMED ON THE RETURNED BATTERIES, (B)(4). (B)(4) DID NOT TRIGGER ANY OF THESE EVENTS. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED TWO CRITICAL BATTERY ALARMS. THE FIRST OCCURRED ON (B)(6) 2016 AT 21:30:18 AND WAS TRIGGERED BY (B)(4). THE SECOND OCCURRED ON (B)(6) 2016 AT 14:54:02 AND WAS TRIGGERED BY (B)(4). THESE CRITICAL BATTERY ALARMS ARE MOST LIKELY DUE TO COMMUNICATION ANOMALIES BETWEEN BATTERY AND CONTROLLER. LOG FILE ANALYSIS ALSO REVEALED MULTIPLE PREMATURE SWITCHING EVENTS INVOLVING (B)(4). ANALYSIS REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED TO COMMUNICATION ANOMALIES BETWEEN BATTERY AND CONTROLLER. THE MOST LIKELY ROOT CAUSE OF THE BEEPING AND PREMATURE SWITCHING EVENTS CAN BE ATTRIBUTED TO A MOMENTARY DISCONNECTIONS OR COMMUNICATION ERROR BETWEEN THE CONTROLLER AND THE BATTERIES. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE COMMUNICATION ERRORS BETWEEN BATTERIES AND CONTROLLERS. (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY MEDICAL PERSONNEL THAT A PATIENT EXPERIENCED BATTERY ISSUES. THE PATIENT REPORTED A CRITICAL BATTERY ALARM (B)(6) ON A BATTERY WITH 3 GREEN BARS. THEY SWAPPED THE BATTERY AND THE ALARM STOPPED. AFTER ATTACHING A NEW BATTERY, A SOLITARY BEEP WAS HEARD 8 TIMES EVERY 15 MINUTES OR SO. IT IS STATED THAT THERE ARE SOLITARY BEEPS WITH NO MESSAGE, WITH BOTH BATTERIES ATTACHED. FINALLY THAT BOTH BATTERIES WILL DRAIN AT THE SAME TIME. THE PATIENT WAS GIVEN 6 NEW BATTERIES WITH THE MOST RECENT RECALL. CRITICAL BATTERY LOGGED (B)(6) WITH NO ALARM. THE BATTERIES WERE EXCHANGED WITH NO REPORTED CONSEQUENCES OR IMPACT ON THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409280 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1