BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 15753623 · Received November 8, 2022

    Report

    Report Number
    1314492-2022-04772
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Report Date
    November 8, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST
    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 REPORTED ISSUE MAY BE RELATED TO FA 2021-056, WHICH IS ASSOCIATED WITH REINFORCING PROPER INTRAVENOUS 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 AN UNSPECIFIED NUMBER OF SPECTRUM IQ PUMP "GAVE VOLUMES DURING INFUSION THAT DID NOT MATCH THE VOLUMES THAT THE PUMPS SAID THEY ADMINISTERED". A 500ML INFUSION RAN FOR OVER ONE HOUR AND THERE WAS STILL A LOT LEFT OVER IN THE BAG. WHEN THE 500ML BAG WAS INFUSED, THE PUMP INDICATED THAT THE VOLUME GIVEN WAS 700ML. THE EVENT OCCURRED IN THE INFUSION CENTER. 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
    2227633 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown