BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 14880990 · Received June 30, 2022

    Report

    Report Number
    1314492-2022-02756
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    May 31, 2022
    Report Date
    July 27, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K220417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED MW5110268 FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. IT CANNOT BE DETERMINED IF A DEVICE OR USER ISSUE CONTRIBUTED TO THE REPORTED EVENT, HOWEVER THERE IS CURRENTLY AN OPEN FIELD ACTION (FA-2021-056) ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND UNDETECTED OR DELAYED DETECTION OF UPSTREAM OCCLUSIONS, WHICH CAN LEAD TO UNDER-INFUSIONS, 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 DURING A CONTINUOUS INFUSION OF FENTANYL 50 MCG/ML WITH A SPECTRUM IQ PUMP, THE PATIENT BECAME INCREASINGLY AGITATED AND LOOKED UNCOMFORTABLE EVEN THOUGH THE PUMP WAS CLEARED AND SHOWED THE VOLUME OF MEDICATION HAD BEEN INFUSED. THE NURSE CHECKED THE PUMP, AND IT ¿SHOWED PUMP RUNNING¿ AND THE INFUSION WAS ¿ON¿. THE INTRAVENOUS (IV) LINE WAS CHECKED; HOWEVER, THERE WAS NO FLOW OBSERVED IN THE TUBING. ACCORDING TO THE REPORTER, THE TUBING LINE WAS RE-PRIMED, REINSERTED INTO THE SPECTRUM PUMP AND "RUN" WAS PRESSED. THE PUMP CONTINUED TO SHOW THE INFUSION WAS IN PROGRESS. THERE WERE NO OCCLUSIONS AND NO DROPS COMING OUT OF THE IV TUBING. THE SPECTRUM PUMP WAS CHANGED, AND THE INFUSION THERAPY WAS RESUMED. THE PATIENT'S CONDITION AND AGITATION "IMPROVED". NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401974 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention FENTANYL