BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 4404510 · Received January 6, 2015

    Report

    Report Number
    2016493-2014-00598
    Event Type
    Injury
    Date Received
    January 6, 2015
    Date of Event
    December 10, 2014
    Report Date
    December 11, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORT OF ERROR CODE 13-1033-149 WAS NOT CONFIRMED. ONLY THE PCU WAS RECEIVED FOR INVESTIGATION. BECAUSE NONE OF THE 4 PUMP MODULES OR THEIR EVENT / ERROR LOGS WERE RETURNED FOR EVALUATION IT WAS NOT POSSIBLE TO CONFIRM THE OCCURRENCE OF THE REPORTED ERROR CODE. ANALYSIS OF THE PCU EVENT LOG IDENTIFIED THAT THE "NEXT" SOFT KEY WAS SHOWN ON THE SCREEN, FOLLOWED BY A TIME OUT EVENT OR "WALKAWAY" ALERT. WHEN THIS OCCURRED ANOTHER TIMER ALSO TRIGGERED A TIME OUT EVENT AT 30 SECONDS AFTER THE "NEXT" SOFT KEY WAS DISPLAYED. THIS SEQUENCE WILL CAUSE THE PCU AND THE SELECTED CHANNEL TO TRANSITION BACK TO THE MAIN STATUS PAGE IF NO USER INTERACTION HAS TAKEN PLACE DURING THIS TIME PERIOD. THE "START" KEYPRESS COINCIDED WITH THE 30 SECOND TIME OUT EVENT, CAUSING AN UNEXPECTED TRANSITION TO A NEW STATE WHICH GENERATED AN INVALID_TRANSITION_FAULT. IN THE NORMAL EXPECTED BEHAVIOR, THE SYSTEM WILL EITHER PROCEED TO START THE INFUSION WHEN THE "START" SOFT KEY IS PRESSED, OR TRANSITION BACK TO THE MAIN STATUS PAGE WHEN THE 30 SECONDS TIMER ELAPSED. WHEN THE EVENT EV_FORM_REQUEST AND STATE ST_START_PROGRAM OCCUR SIMULTANEOUSLY WITHIN THE NARROW TIMING WINDOW (IN MICRO SECONDS) IT IS POSSIBLE THE SYSTEM CAN TRANSITION TO AN UNEXPECTED STATE, RESULTING IN A SYSTEM FAULT. INTERNAL INSPECTION OF THE PCU DID NOT IDENTIFY ANY EVIDENCE OF FLUID INGRESS, HOWEVER IT WAS NOTED THE LCD DISPLAY FLEXI CONNECTOR LOCKING MECHANISM WAS BROKEN. A PERFORMANCE VERIFICATION PROCEDURE WAS COMPLETED AND ALL RESULTS WERE WITHIN SPECIFICATION. VARIOUS ATTEMPTS TO REPRODUCE THE ERROR WERE UNSUCCESSFUL. THE CAUSE OF THE ERROR WAS DETERMINED TO BE DUE TO THE RACE CONDITION WHICH OCCURRED WHEN AN EVENT EV_FORM_REQUEST AND THE STATE ST_START_PROGRAM OCCURRED SIMULTANEOUSLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INTUBATED PATIENT WAS BEING INFUSED WITH NORADRENALINE, MORPHINE/MIDAZOLAM AND AN UNSPECIFIED DRUG FOR APPROXIMATELY 6-7 HOURS WHEN THE PUMP ALARMED WITH ERROR CODE 13-1033-149. ICU STAFF CHANGED PCU AND LVP MODULES. PATIENT REQUIRED ARAMINE FOR BP DROP. PATIENT CURRENTLY STABLE. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6492 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION CORPORATION 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (3) ALARIS PRIMARY TUBINGS, MODEL/LOT UNK,