BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3181746 · Received June 6, 2013

    Report

    Report Number
    1314492-2013-00714
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SECONDARY INFUSIONS, THE ALBUMIN WILL NOT FLOW CAUSING FLUID TO BE PULLED FROM THE PRIMARY BAG. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252051 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1