BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3884228 · Received May 20, 2014

    Report

    Report Number
    2916596-2014-00801
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    November 11, 2013
    Report Date
    April 21, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER SERIAL NUMBER (B)(4) WAS RETURNED TO THE MANUFACTURER FOR EVAL. THE REPORTED EVENT OF A RED HEART ALARM WAS CONFIRMED BY THE DATA LOG FILE RETRIEVED FROM THE RETURNED SYSTEM CONTROLLER. REVIEW OF THE LOG FILE REVEALED EVENTS ASSOCIATED WITH PUMP DISCONNECTION AND POWER INTERRUPTIONS. THE RED HEART ALARMS RECORDED IN THE LOG FILE APPEAR TO BE ASSOCIATED WITH THE PUMP STOP EVENTS RELATED TO THE PUMP BEING DISCONNECTED. THE LOG FILE ALSO RECORDED POWER CABLE DISCONNECT EVENTS, WHICH APPEARED TO BE DUE TO A BATTERY VOLTAGE LEVEL FAULT ASSOCIATED WITH THE WHITE POWER LEAD. THE ANALYSIS COULD NOT DETERMINE THE ROOT CAUSE THAT LED TO THE BATTERY VOLTAGE LEVEL FAULT CAPTURED IN THE LOG FILE; HOWEVER, CONTRIBUTING FACTORS SUCH AS AN INTERNAL ISSUE WITH THE BATTERY ITSELF, THE BATTERY CLIP OR BOTH CAN INITIATE A POWER CABLE DISCONNECT ALARM. THE CAUSE OF SUDDEN POWER LOSS AND PUMP DISCONNECT EVENTS RECORDED IN THE LOG FILE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVAL. THE SYSTEM CONTROLLER ASSOCIATED WITH THIS EVENT FUNCTIONED AS INTENDED THROUGHOUT THE EVAL AND DOES NOT APPEAR TO BE CAUSE OF THE REPORTED EVENTS. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE NEW SYSTEM CONTROLLER GIVEN TO THE PT FAILED. THE PT WAS SWITCHING OUT TO BATTERY POWER AND ALL THE LIGHTS ON THE SYSTEM CONTROLLER LIT UP, WENT OUT, AND THE RED HEART ALARM STARTED. THE VAD COORD. CHECKED THE HISTORY WHICH REFLECTED CONTINUOUS POWER CABLE DISCONNECTS, BUT PER THE PT, HE WAS ON THE POWER MODULE AT THE TIME AND HAD NOT BEEN SWITCHING OUT HIS CABLE. THE CABLE AND BATTERIES ARE NEW. HE STATED THAT HE EXPERIENCED NO OTHER ALARMS OTHER THAN THE RED HEART ALARM AS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298962 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 119320

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR