BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ

    MDR report key: 20629494 · Received November 7, 2024

    Report

    Report Number
    20629494
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT BEING ADMITTED FROM AN OUTSIDE FOR A GI BLEED REQUIRING A BLAKEMORE/MINNESOTA TUBE ON 40 OF LEVO AND 0.04 OF VASO. SHORTLY AFTER TRANSITION FROM PRESSORS TO ICU PRESSORS, PATIENT DEVELOPED SUDDEN SEVERE HYPOTENSION TO A LOW OF 50/31 WITH A MAP OF 39 FOR APPROXIMATELY 5 MINUTES. LINE, TUBING, CLAMPS, AND PUMPS CHECKED WITH NO ISSUES NOTED. DOSE INCREASED TO 100 OF LEVO AND 0.08 OF VASO WITHOUT RECOVERY. ULTIMATELY PATIENT WAS GIVEN 1MG EPI PUSH. AT APPROXIMATELY THE SAME TIME IT WAS FOUND THAT THE LEVO DRIP WAS NOT INFUSING WITH NO DRIPS FALLING IN DRIP CONTAINER AND A SMALL KINK IN THE TUBING NOTED. NO ALARMS WERE OCCURRING TO IDENTIFY AN UPSTREAM OCCLUSION. UPON CORRECTION OF THE KINK PATIENT IMMEDIATELY BECAME HYPERTENSIVE UP TO A MAX OF 232/121 WITH A MAP OF 163 AND REMAINED SO FOR ABOUT 5 MINUTES DESPITE RAMPING DOWN ON CARRIER/PRESSOR DOSES. LEVO SWITCHED TO ANOTHER PUMP WITH IMPROVEMENT IN FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78758 SPECTRUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION SPECTRUM IQ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown