BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS INFUSION PUMP

    MDR report key: 4093117 · Received September 10, 2014

    Report

    Report Number
    MW5038182
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 18, 2014
    Manufacturer
    CARFUSION CORP
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) POST PARTUM PT RECEIVING IV FLUIDS AFTER DELIVERY. ALARIS IV PUMP ALARMING WHILE USED ON PT. PUMP MODULE SHOWED "PT SIDE OCCLUDED" ERROR. RN CHANGED TUBING AND EXAMINED IV SITE. ALARIS PUMP CONTINUED TO DISPLAY "PT SIDE OCCLUDED" ERROR MESSAGE. MODULES AND PCU REPLACED WITHOUT FURTHER COMPLICATIONS. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559759 ALARIS INFUSION PUMP ALARIS INFUSION PUMP FRN CARFUSION CORP UNAVAILABLE UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR