BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6171223 · Received December 13, 2016

    Report

    Report Number
    3007042319-2016-04413
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 23, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE INVOLVED IN THIS EVENT: BATTERY/(B)(4); CAT#1650DE: EXP. DATE: 02/28/2017; MFG. DATE: 02/28/2016. 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 (IFU) PROVIDES INSTRUCTIONS FOR PROPERLY CONNECTING THE POWER SOURCES. IT INSTRUCTS TO LINE UP THE SOLID WHITE ARROW ON THE CONNECTOR WITH THE WHITE DOT. GENTLY PUSH THE CABLE INTO THE CONTROLLER. DO NOT TWIST THE CONNECTOR, BUT ALLOW IT TO NATURALLY LOCK IN PLACE. A SUCCESSFUL CONNECTION WILL RESULT IN AN AUDIBLE CLICK. THE IFU CAUTIONS, "DO NOT FORCE CONNECTORS TOGETHER WITHOUT PROPER ALIGNMENT. FORCING TOGETHER MISALIGNED CONNECTORS MAY DAMAGE THE CONNECTORS." IF BOTH POWER SOURCES ARE DISCONNECTED FROM THE CONTROLLER, A LOUD, CONTINUOUS ALARM WILL SOUND AND THERE WILL BE NO MESSAGE ON THE CONTROLLER DISPLAY. THE PUMP IS NOT PUMPING AND POWER SOURCES SHOULD BE CONNECTED IMMEDIATELY. IF THIS ACTION DOES NOT RESOLVE THE ALARM CONDITION REPLACE THE CONTROLLER." THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE 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 BATTERIES AND CONTROLLERS ARE OUTLINED. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED (12/13/2016) FROM THE FIELD CONFIRMED THAT THE PATIENT EXPERIENCED A "NO POWER" ALARM WHICH PROMPTED HER TO REPLACE BOTH POWER SOURCES. THERE WAS NOT SUSPECTED TO BE A MALFUNCTION OF THE CONTROLLER. THE ISSUE WAS RESOLVED WITH THE REPLACEMENT DEVICES. TWO BATTERIES (B)(4) WERE NOT RETURNED FOR EVALUATION. ANALYSIS OF THE DEVICES COULD NOT BE PERFORMED SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION.  A REVIEW OF THE DEVICES' INCOMING INSPECTION RECORDS INDICATED THE DEVICES MET THE INTERNAL REQUIREMENTS PRIOR TO THEIR QUALITY ASSURANCE RELEASE PROCESS.  LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED THE SMR SOFTWARE. THE SOFTWARE UPGRADE CONTAINS A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. ANALYSIS OF THE DATA AND EVENT LOG FILES REVEALED A CONTROLLER POWER UP ON (B)(6) 2016 AT 23:06:52.  THIS INCIDENT APPEARS TO BE THE RESULT OF A DOUBLE POWER DISCONNECTION.  DATA LOGS SHOW THAT AT THE TIME, (B)(4) WAS CONNECTED TO  POWER PORT 1 WITH APPROXIMATELY 59% RELATIVE STATE OF CHARGE (RSOC) AND AN AC ADAPTER WAS CONNECTED TO POWER PORT 2. THE SAME DEVICES CONTINUED CONNECTED TO THE CONTROLLER AFTER THE POWER-UP. THE REPORTED LOSS OF POWER BY (DOUBLE DISCONNECT) WAS CONFIRMED VIA LOGS; HOWEVER, IT DID NOT INVOLVE ANY OF THE BATTERIES IN QUESTION (B)(4). THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A DOUBLE POWER DISCONNECTION. 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 THAT WITH BOTH BATTERIES CONNECTED TO THE CONTROLLER, THEY BOTH TURNED OFF SUDDENLY ACTIVATING AN ALARM. LOG FILES WERE SENT AND BOTH BATTERIES WERE EXCHANGED WITHOUT CONSEQUENCE TO THE PATIENT.  NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822770 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR