BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ

    MDR report key: 21689591 · Received March 25, 2025

    Report

    Report Number
    1314492-2025-00683
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Report Date
    April 22, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION H6 MEDICAL DEVICE PROBLEM CODES CORRECTED TO A070908. ADDITIONAL INFORMATION: D9, H3, H6, H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE REPORTED PROBLEM "NO UPSTREAM OCCLUSION" WAS NOT REPRODUCED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 HAD NO UPSTREAM OCCLUSION. THIS OCCURRED DURING TESTING IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133187 SPECTRUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 3570009 NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown