BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 1053032 · Received May 17, 2008

    Report

    Report Number
    1053032
    Event Type
    Malfunction
    Date Received
    May 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    May 17, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PROGRAMMED IVPB AT 100 ML/HR FOR A TOTAL VOLUME OF 250 ML AT 0900. THE INFUSION WAS COMPLETED AT 1100; HOWEVER THE TOTAL VOLUME ON THE SCREEN SHOW 45 ML LEFT. MAIN IVF SUPPOSED TO BE 75 ML/HR BUT PATIENT WAS RECEIVING 100ML/HR. BIOMED ASSESSMENT: THE PUMP OPERATION AND ACCURACY WERE VERIFIED IN BIOMED AND ALL TESTS WERE WITHIN SPECIFICATIONS. THE PUMP MODULE WILL NORMALLY CONTINUE TO PUMP FOR THE DURATION OF THE CALCULATED TIME AS PROGRAMMED PRIOR TO SWITCHING BACK TO THE MAIN IV RATE; HOWEVER, THIS WAS NOT THE PROBLEM. THE DEVICE WAS RETURNED TO THE MANUFACTURER:MULTIPLE TESTS WERE CONDUCTED AND THE PUMP OPERATED ACCORDING TO SPECIFICATIONS. THE CONCLUSIONS: THE PUMP APPEARED TO HAVE OPERATED WITHIN SPECIFICATIONS. NO MALFUNCTION IS BELIEVED TO HAVE OCCURRED. THE ROOT CAUSE OF THE REPORTED PROBLEM IS UNKNOWN. BASED ON THIS, THE EDUCATORS WILL SHARE THIS REPORT AND REVIEW THE LOADING AND INFUSION METHODOLOGIES FOR THE PUMP. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP, IV, MODULE FRN ALARIS MEDICAL SYSTEMS, INC. 8100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR