BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 16432418 · Received February 23, 2023

    Report

    Report Number
    1314492-2023-00555
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 PROVIDED TWO PHOTOS DISPLAYING AN "UPSTREAM OCCLUSION!" ALARM SCREEN AND A "SUSPEND ALL UPSTREAM OCCLUSION ALARMS" SCREEN. IT IS NOT CLEAR IF THE USER SUSPENDED OCCLUSION ALARMS FOR THE INFUSION. A DEFINITIVE CAUSE COULD NOT BE DETERMINED, WITH THE INFORMATION PROVIDED HOWEVER THE PROBLEM DESCRIPTION MAY POTENTIALLY RELATED TO OPEN FA 2021-056. ADDITIONALLY, IT IS UNCLEAR IF THE USER ASSESSED AND CLEARED THE OCCLUSION FROM THE IV LINE AT THE TIME OF ALARM. IF AN OCCLUSION IS NOT FULLY RESOLVED BEFORE RESTARTING THE INFUSION, THE ALARM MAY NOT RECUR AS EXPECTED, WHICH IS ALSO DESCRIBED IN FA 2021-056. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP UNDER INFUSED DURING VASOPRESSOR THERAPY AT THE CRITICAL CARE UNIT OVER AN APPROXIMATE 4 HOUR PERIOD. 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
    514948 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NI.