BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 15429518 · Received September 15, 2022

    Report

    Report Number
    1314492-2022-03957
    Event Type
    Injury
    Date Received
    September 15, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K220417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2022. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A DEFINITIVE CAUSE COULD NOT BE DETERMINED, HOWEVER THE PROBLEM DESCRIPTION MAY POTENTIALLY BE RELATED TO FA 2021-056, WHICH IS CURRENTLY ONGOING AND IS ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSIONS FOR SPECTRUM PUMPS, WHICH CAN CAUSE UNDER-INFUSIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT INFUSION WITH A SPECTRUM IQ PUMP, THE "PUMP WAS DISCOVERED TO NOT INFUSE FOR SEVERAL HOURS". SUBSEQUENTLY, THE PATIENT UNDERWENT A CAESAREAN-SECTION (C-SECTION) DELIVERY. THE EXACT INDICATION FOR DELIVERY BY C-SECTION FOR THE PATIENT WAS NOT REPORTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PATIENT EVENT, PATIENT¿S DEMOGRAPHICS, MEDICAL HISTORY, OR ANY ALARMS THAT WERE GENERATED BY THE PUMP WAS UNABLE TO BE OBTAINED AND NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521458 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention