BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM

    MDR report key: 2892855 · Received December 21, 2012

    Report

    Report Number
    MW5028391
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 16, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BAXTER/SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SIGMA SPECTRUM INFUSION PUMP S/N (B)(4) FAILED TO ALARM FOR AN UPSTREAM OCCLUSION CONDITION. THE PUMP DISPLAYED A DELIVERED VOLUME THAT DID NOT ACCURATELY REFLECT THE ACTUAL DELIVERED VOLUME. THE CLINICIAN STATES: "THE PT WAS ON A PRECEDEX DRIP AND IT WAS LATER NOTICED THAT THE IV PUMP HAD NOT INFUSED THE EXPECTED VOLUME. THE TUBING WAS PARTIALLY OCCLUDED BY THE SLIDE CLAMP AND THE PUMP SHOULD HAVE ALARMED TO NOTIFY THE RN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM INFUSION PUMP FRN BAXTER/SIGMA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other