BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ IV PUMP

    MDR report key: 18578984 · Received January 25, 2024

    Report

    Report Number
    18578984
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    December 15, 2023
    Report Date
    December 19, 2023
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BAXTER IV PUMP FAILURE. PATIENT ON REMIFENTANIL INFUSION DURING SPINE CASE. PUMP PROGRAMMED CORRECTLY; HOWEVER, MEDICATION WAS NOT INFUSING. VOLUME IN BAG WAS FOUND TO BE NOT EMPTYING. NO PATIENT HARM OCCURRED. CLINICAL ENGINEERING INTERROGATING PUMP AS OF [REDACTED DATE]. MANUFACTURER RESPONSE FOR IV INFUSION PUMP, SPECTRUM IQ IV PUMP (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056923 SPECTRUM IQ IV PUMP PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 35700009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown