BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 6921253 · Received October 6, 2017

    Report

    Report Number
    3007042319-2017-03587
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 10, 2017
    Report Date
    December 11, 2018
    Manufacturer
    HEARTWARE
    Product Code
    DSQ
    UDI-DI
    00888707000376
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1917-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE BATTERY (BAT553444) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THE REPORTED CRITICAL BATTERY ALARMS AND PUMP STOP WERE CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED TWO (2) CRITICAL BATTERY ALARMS ON (B)(6) 2017, AT 12:59:14 AND 19:3536, INVOLVING BAT553444. IN EACH INSTANCE, THE BATTERY WENT FROM A HIGH RELATIVE STATE OF CHARGE (RSOC) TO 0% RSOC. THIS OBSERVATION IS INDICATIVE OF A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. A CONTROLLER POWER UP WAS RECORDED ON (B)(6) 2017 AT 09:18:26. BEFORE THE LOSS OF POWER, BAT553453 WAS CONNECTED TO POWER PORT 1 WITH 49% RELATIVE STATE OF CHARGE (RSOC) AND BAT553351 WAS CONNECTED TO POWER PORT 2 WITH 45% RSOC. AFTER THE LOSS OF POWER, BAT553444 WAS CONNECTED TO POWER PORT 1 WITH 97% RSOC AND BAT554070 WAS CONNECTED TO POWER PORT 2 WITH 98% RSOC. BASED ON LOG FILE ANALYSIS, THE CRITICAL BATTERY ALARMS DID NOT OCCUR ON THE SAME DAY AS THE CONTROLLER POWER UP EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERY REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE REPORTED POWER CONSUMPTION COULD NOT BE CONFIRMED; HOWEVER, POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS WERE RECORDED INVOLVING THIS BATTERY. THIS WAS MOST LIKELY PERCEIVED BY THE PATIENT AS THE REPORTED POWER CONSUMPTION ISSUE. THE MOST LIKELY ROOT CAUSE OF THE LOSS OF POWER MAY HAVE OCCURRED DUE TO A DISCONNECTION OF BOTH POWER SOURCES, GIVEN THAT BOTH POWER SOURCES CONNECTED PRIOR TO THE LOSS OF POWER WERE REPLACED. THE MOST LIKELY ROOT CAUSE OF THE "CRITICAL BATTERY" ALARM AND POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERY. AN INTERNAL INVESTIGATION IS INVESTIGATING COMMUNICATION ERRORS. OF NOTE, THE CONTROLLER, CON103717, IN USE DURING THE EVENT DID NOT HAVE THE SOFTWARE MASTER RECORD (SMR) UPGRADE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT STATED BATTERY WENT "HAYWIRE" AND WAS AT FULL BATTERY CAPACITY THEN DRAINED ALMOST IMMEDIATELY. CONTROLLER LOG FILES WERE DOWNLOADED AND SENT TO MANUFACTURER WHICH CONFIRMED THAT THE CULPRIT BATTERY TRIGGERED TWO "CRITICAL BATTERY" ALARMS. THE EVENT WAS REPORTEDLY RESULTED IN A PUMP STOP. THE BATTERY WAS REPLACED WITH NO REPORTED PATIENT CONSEQUENCE. THERE WERE NO FURTHER CONTROLLER ALARMS AFTER THE BATTERY WAS EXCHANGED. THE BATTERY CAPACITY WAS GREATER THAN 10% WHEN THE EVENTS OCCURRED. THERE WAS NO DAMAGE NOTED TO THE BATTERY OR TO ITS CONNECTORS. IT IS UNKNOWN IF THE PATIENT HAS A HISTORY OF CHARGING THE BATTERY BEFORE IT IS FULLY DEPLETED. OF NOTE, THE CONTROLLER WAS EXCHANGED AT THE SAME OFFICE VISIT TO CONTROLLER 2.0.  NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702580 HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE 00888707000376

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR