BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ

    MDR report key: 18508671 · Received January 12, 2024

    Report

    Report Number
    1314492-2023-05027
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 20, 2023
    Report Date
    December 13, 2024
    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

    CORRECTION: D1: BRAND NAME, D4: MODEL #, D4: UNIQUE IDENTIFIER (UDI) #, G4: COMBINATION PRODUCT ADDITIONAL INFORMATION: H6, H11. H11: 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. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED HOWEVER THE ISSUE DESCRIBED ALIGNS WITH FA-2024-023 WHICH IS RELATED TO THE BATTERY MODULE SOFTWARE. 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 PUMP WAS NOT SENDING STATUS MESSAGES WHILE CONTINUING TO RUN THE PROGRAMMED THERAPY. 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
    2058474 SPECTRUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 3570009 NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NI.