BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 7288942 · Received February 22, 2018

    Report

    Report Number
    3007042319-2018-00751
    Event Type
    Death
    Date Received
    February 22, 2018
    Date of Event
    February 15, 2018
    Report Date
    November 27, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 BATTERY /(B)(4)/ MODEL #: 1420 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY /(B)(4)/ MODEL #: 1650DE (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY/ (B)(4)/ MODEL #: 1650DE (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PUMP ((B)(4)) WAS NOT RETURNED FOR EVALUATION. THE CONTROLLER ((B)(4)) AND FOUR BATTERIES ( (B)(4)) WERE RETURNED FOR EVALUATION. THERE WAS NO PERFORMANCE ALLEGATION AGAINST THE BATTERIES (B)(4). VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT THE CONTROLLER AND BATTERIES PASSED FUNCTIONAL TESTING AND VISUAL INSPECTION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. A REVIEW OF THE ALARM FILE REVEALED SEVERAL CRITICAL BATTERY AND CONTROLLER FAULT ALARMS. THE CRITICAL BATTERY ALARMS WERE THE RESULT OF THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10% RELATIVE STATE OF CHARGE (RSOC). A CONTROLLER FAULT ALARM WILL OCCUR IF THE BATTERY IS APPROACHING 0% RSOC. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, BATTERY /(B)(4)/ MODEL #: 1420 /(B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY /(B)(4)/ MODEL #: 1650DE / (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY / (B)(4)/ MODEL #: 1650DE /(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 AND DESTINATION THERAPY 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. PRODUCT EVENT SUMMARY: THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, (B)(4)/MODEL #: 1420/ EXPIRATION DATE: 03-31-2018. HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, (B)(4)/MODEL #: 1650DE/EXPIRATION DATE: 07-31-2018, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY, (B)(4)/MODEL #: 1650DE/EXPIRATION DATE: 09-30-2018, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WERE MULTIPLE CRITICAL BATTERY ALARMS AND CONTROLLER FAULT ALARMS ON (B)(6) 2018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN ACCIDENTAL FALL, BROKE HIS NECK AND DIED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133250 HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death