BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ

    MDR report key: 18672941 · Received February 8, 2024

    Report

    Report Number
    1314492-2024-00303
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Report Date
    August 5, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H11: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, ALARMING UPSTREAM OCCLUSION CONSTANTLY WHEN INFUSION IS CLOSE TO BEING DONE WAS NOT REPRODUCED. A REVIEW OF THE EVENT HISTORY LOG REVEALED "UPSTREAM OCCLUSION!" MESSAGES. THE EVENT HISTORY LOG CANNOT CONFIRM IF THE ALARMS WERE TRUE OF FALSE. A SERVICE HISTORY REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS VERIFIED. THE REPORTED PROBLEM MAY POTENTIALLY BE RELATED TO FA 2023-034. FA 2023-034 STATES THAT SOFTWARE VERSIONS V9.02.01 AND V8.01.01 WERE DETERMINED TO BE INEFFECTIVE IN PREVENTING FALSE UPSTREAM OCCLUSION ALARMS, AND THEREFORE THE IMPACTED DEVICES WILL BE DOWNGRADED TO THE PREVIOUS SOFTWARE VERSIONS UNTIL A NEW FIX IS IDENTIFIED. THE REPORTED PROBLEM IS FAILED RATE TEST. FLOW ACCURACY TEST WAS NOT REPRODUCED. THE REPORTED CONDITION WAS NOT VERIFIED. 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 INFUSION PUMP WAS ALARMING UPSTREAM OCCLUSION CONSTANTLY WHEN INFUSION WAS CLOSE TO BEING DONE. THE PUMP ALSO FAILED RATE TESTING IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50865 SPECTRUM IQ PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 3570009 N/A 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown