BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3822701 · Received February 12, 2014

    Report

    Report Number
    2916596-2014-00167
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT OF THE PUMP STOPPING IMMEDIATELY AFTER BEING STARTED WAS CONFIRMED WITH THE EVENT DATA RETRIEVED FROM THE RETURNED SYSTEM CONTROLLER. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED USING THE MANUFACTURER¿S LABORATORY EQUIPMENT AND WAS FOUND TO FUNCTION AS INTENDED; HOWEVER, ADDITIONAL TESTING WAS PERFORMED IN WHICH A LOW CURRENT CONDITION WAS INDUCED, WHERE AIR WAS INTRODUCED INTO THE SUCTION SIDE OF THE TEST PUMP, RESULTED IN AN INTERRUPTION IN PUMP FUNCTION SIMILAR TO WHAT WAS REPORTED. THE EVENT APPEARED TO BE RELATED TO A LOW CURRENT CONDITION DURING THE INITIALIZATION OF PUMP FUNCTION. ALTHOUGH LABORATORY TESTING WAS ABLE TO INDUCE A SIMILAR LOW CURRENT CONDITION, THE ANALYSIS COULD NOT DETERMINE THE SPECIFIC ROOT CAUSE THAT CONTRIBUTED TO THE LOW CURRENT CONDITION CAPTURED DURING THE REPORTED EVENT. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE MFR IS ATTEMPTING TO ACQUIRE THE SUSPECT SYSTEM CONTROLLER FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). DURING THE IMPLANT PROCEDURE AND SPECIFICALLY DURING THE SET UP FOR PT SUPPORT, THE PUMP STOPPED SPONTANEOUSLY WHEN IT WAS STARTED ON TWO DIFFERENT OCCASIONS. THE HOSPITAL REPLACED THE SYSTEM CONTROLLER AND THE SITUATION WAS RESOLVED. NO EFFECTS TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94033 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106017 134611

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention