BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 16269055 · Received January 30, 2023

    Report

    Report Number
    1314492-2023-00160
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Report Date
    January 30, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CUSTOMER PHOTO OF THE TUBING SHOWS AN UNLOADED SEGMENT OF TUBING THAT IS VISIBLY KINKED. THE LOCATION OF THE KINKS ON THE TUBING CANNOT BE DISTINGUISHED THROUGH THE PHOTO. A DEFINITIVE CAUSE COULD NOT BE DETERMINED AND IT IS UNKNOWN IF THE TUBING WAS KINKED ABOVE OR BELOW THE PUMP, HOWEVER THE PROBLEM DESCRIPTION MAY POTENTIALLY RELATED TO AN OPEN FA 2021-056, WHICH IS ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSIONS FOR SPECTRUM PUMPS.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 PUMP WAS NOT ALARMING WHEN THE BAXTER TUBING WAS KINKED DURING AN UNSPECIFIED PROCESS STEP AT THE CARDIOVASCULAR UNIT (CVU) AND INTENSIVE CARE UNIT (ICU). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638726 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CLEARLINK DUO-VENT C-FLO SET