BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6255832 · Received January 17, 2017

    Report

    Report Number
    3007042319-2016-04479
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 HVAD CONTROLLER IS A MICROPROCESSOR UNIT THAT CONTROLS AND MANAGES THE HEARTWARE SYSTEM OPERATION. IT SENDS POWER AND OPERATING SIGNALS TO THE BLOOD PUMP AND COLLECTS INFORMATION FROM THE PUMP. THE CONTROLLER'S INTERNAL, NON-REPLACEABLE, RECHARGEABLE BATTERY IS USED TO POWER AN AUDIBLE "NO POWER" ALARM WHEN BOTH POWER SOURCES ARE DISCONNECTED. THE HVAD CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION: EITHER TWO BATTERIES, OR ONE BATTERY AND AN AC ADAPTER OR DC ADAPTER. THE INSTRUCTIONS FOR USE (IFU) PROVIDES GUIDANCE REGARDING CONTROLLER VISUAL AND AUDITORY ALARMS. THE "NO POWER" ALARM PROVIDES A LOUD CONTINUOUS AUDITORY ALARM THAT USERS ARE UNABLE TO MUTE. THE IFU EXPLAINS THAT THIS CRITICAL ALARM INDICATES THAT THE CONTROLLER IS NOT PROVIDING POWER TO THE PUMP AND THAT THE PUMP HAS STOPPED. THEY ARE INSTRUCTED THAT POTENTIAL ACTIONS TO RESOLVE THE ISSUE INCLUDE CONNECTING TWO NEW POWER SOURCES, EXCHANGING THE CONTROLLER AND CONTACTING HEARTWARE CLINICAL SUPPORT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. RETAINED BY PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE FOR THIS EVENT: SERIAL # :(B)(4) CATALOG # 1430 EXP. DATE: 12/31/2015. DEVICE WAS AVAILABLE FOR EVALUATION. RETURNED TO MANUFACTURER ON 12/13/2016. DEVICE WAS EVALUATED BY MANUFACTURER. MFR DATE: 12/31/2014. (B)(4). IT WAS REPORTED THAT THE CONTROLLER LOSS POWER DURING A POWER SOURCE EXCHANGE. THE CONTROLLER AC ADAPTER WAS RETURNED FOR EVALUATION. THE CONTROLLER WAS NOT RETURNED; A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED CONTROLLER MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED A CONTROLLER POWER UP EVENT ON (B)(6) 2016 AT 07:25:02. THE DATA POINT PRIOR TO THE CONTROLLER POWER UP EVENT REVEALED THAT A CONTROLLER AC ADAPTER WAS CONNECTED TO POWER PORT 1 AND (B)(4) WAS CONNECTED TO POWER PORT 2 WITH 95% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT AFTER THE CONTROLLER POWER UP EVENT REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT 1 AND (B)(4) WAS CONNECTED TO POWER PORT 2 WITH 92% RSOC. (B)(4) ON POWER PORT 1 EXPERIENCED A DISCONNECTION AND RECONNECTION WITHIN THE PAST 15 MINUTES. NO ALARMS WERE LOGGED NEAR THE REPORTED EVENT DATE. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AC ADAPTER REVEALED THAT THE UNIT PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE CONTROLLER AC ADAPTER'S OUTPUT CABLE WAS PULLED AND TWISTED IN AN ATTEMPT TO INDUCE A DISCONNECTION. THE RESULTS REVEALED THAT THE AC ADAPTER WAS MECHANICALLY AND ELECTRICALLY STABLE, A DISCONNECTION DID NOT OCCUR. THE REPORTED EVENT COULD NOT BE DUPLICATED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A  DISCONNECTION OF BOTH POWER SOURCES. 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

    A REPORT WAS RECEIVED THAT THE CONTROLLER WAS CONNECTED TO A BATTERY AND CAC ADAPTER WHEN THE PATIENT DECIDED TO CHANGE THE BATTERY AND THE CONTROLLER SIGNALED A "NO POWER" ALARM. SHE IMMEDIATELY RE-CONNECTED THE BATTERY AND THE ALARM STOPPED. THE GREEN LIGHT WAS ILLUMINATED WHEN THE CAC ADAPTER WAS PLUGGED INTO THE WALL OUTLET AND INTERNAL WIRES WERE NOT EXPOSED. AFTER VERIFYING THAT THE SIGNAL OF THE CAC ADAPTER WAS NOT RECOGNIZED ON THE CONTROLLER, THE PATIENT DECIDED TO SWITCH THE CAC ADAPTER TO HER BACKUP CAC ADAPTER WHICH FUNCTIONED WITHOUT ANY ISSUE. THE PATIENT WAS ABLE TO SWITCH OUT THE DEPLETED BATTERY WITH THE NEW CAC ADAPTER WITHOUT ANY CONTROLLER ALARMS. THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT. THE PUMP HAD STOPPED FOR "A FEW SECONDS". THE SITE INDICATED THAT THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION ASSOCIATED WITH THE BATTERY AND CONTROLLER. IT IS UNKNOWN IF AN AUDIBLE CLICK WAS HEARD WHEN THE CAC ADAPTER WAS CONNECTED TO THE CONTROLLER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38795 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR