BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 16300385 · Received February 3, 2023

    Report

    Report Number
    1314492-2023-00256
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    November 6, 2022
    Report Date
    February 3, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K222048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED MEDWATCH (B)(4) FOR THIS EVENT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE USER REPORTED THAT THE TUBING WAS KINKED IN THE NARCOTIC LOCKBOX, HOWEVER THE PUMP WAS NOT ALARMING. THE REPORTED PROBLEM DESCRIPTION MAY BE RELATED TO FA 2021-056, WHICH IS ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSIONS FOR SPECTRUM PUMPS. THE PUMP MAY NOT DETECT OR MAY BE SLOW TO DETECT A PARTIAL OCCLUSION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM IQ INFUSION PUMP WAS BEING USED FOR PATIENT INFUSION OF LEVOPHED WHEN THE PATIENT BLOOD PRESSURE (BP) READING WAS NOTED TO BE BELOW THE EXPECTED GOAL WITHOUT A DEFINITIVE CAUSE AT THE CRITICAL CARE UNIT (CCU). THE LEVOPHED DRIP WAS TITRATED UP WITH MILD IMPROVEMENT FIFTEEN MINUTES LATER. THIRTY MINUTES LATER ,THE BLOOD PRESSURE WAS EVEN LOWER THAN THE PREVIOUS READINGS. REPORTEDLY, THE TUBING SET WAS KINKED IN THE NARCOTIC LOCKBOX AND COMPLETELY OCCLUDED. THE PUMP DID NOT ALARM AT ALL DURING THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64607 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening LEVOPHED