BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 1080834 · Received July 9, 2008

    Report

    Report Number
    1080834
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    April 30, 2008
    Report Date
    July 9, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ALARIS INFUSION PUMP WITH SYRINGE MODULE SEEMS TO RESET ITSELF FOR TOTAL VOLUME INFUSED. PUMP REPORTS 0.19CC INFUSED. A HOUR LATER, IT WAS REPORTED THAT 0.15CC INFUSED WITHOUT MANUAL RESET BY USER. SYRINGE STARTED WITH TOTAL VOLUME OF 50CC. AT TIME THAT VARIANCE NOTICED, VOLUME IN SYRINGE NOT LESS THAN 49CC. INFUSION STARTED 3 1/2 HOURS PRIOR TO THE VARIANCE. PUMP CHANGED, TAGGED, AND REMOVED FROM THE ROOM. CLINICAL ENGINEERING EVALUATION: INVESTIGATED KEYSTROKE LOGS OF SYRINGE MODULE AND PCU INVOLVED IN INCIDENT. WERE NOT ABLE TO VERIFY THE ISSUE, HOWEVER IT WAS NOTED THAT A PRESSURE SENSING DISK WAS USED ON THE SYRINGE MODULE. SHORTLY AFTER THE INFUSION STARTED, THE SYRINGE MODULE LOG NOTES "DISC PRESENT = TRUE", WHILE THE PCU NOTES "DISC PRESENT = FALSE". THE PCU SHOULD HAVE READ "TRUE", THEREFORE THERE IS THOUGHT TO BE AN UNKNOWN SOFTWARE OR HARDWARE ISSUE WITH THE PCU. BOTH THE SYRINGE MODULE AND PCU, AS WELL AS THE LVP ATTACHED TO THE PUMP AT THE TIME WILL BE SENT TO ALARIS FOR FURTHER INVESTIGATION.====================== MANUFACTURER RESPONSE FOR INFUSION PUMP AND SYRINGE MODULE, ALARIS SYSTEM======================NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP, IV,CPU FRN ALARIS MEDICAL SYSTEMS, INC. 8000BX03EE *
    2 * PUMP, IV, MODULE FRN ALARIS MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA