BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    SPECTRUM IQ

    MDR report key: 12922900 · Received December 3, 2021

    Report

    Report Number
    12922900
    Event Type
    No answer provided
    Date Received
    December 3, 2021
    Date of Event
    October 23, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NO UPSTREAM ALARMS NOTED WHEN LEVO WAS NOT INFUSING, SIGNIFICANT INCREASED LEVO REQUIREMENT OVER THE COURSE OF THE DAY, ADDED VASO. ALINE INSERTED. VOLUME IN BAG DID NOT MATCH WHAT THE PUMP WAS SAYING FOR HOW MUCH WAS LEFT. FOUND CRIMP IN LINE WHEN SWITCHING CONCENTRATION. PUMP SEQUESTERED BY RN. CLINICAL ENGINEERING INTERROGATED THE PUMP. THEY FOUND THERE WERE 8 UPSTREAM OCCLUSION ALARMS IN THE TWO DAYS PRIOR, BUT THE PUMP TUBING WAS NOT RELOADED SO IT DID NOT ALARM AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825940 SPECTRUM IQ PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 35700009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown