BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ

    MDR report key: 18935792 · Received March 19, 2024

    Report

    Report Number
    1314492-2024-00761
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    CORRECTION: D1: BRAND NAME, D4: MODEL #, D4: UNIQUE IDENTIFIER (UDI) #, G4: COMBINATION PRODUCT., F10/H6: MEDICAL DEVICE PROBLEM CODES A070911. ADDITIONAL INFORMATION: B5, D9, H3, H6, H11. B5: ADDITIONAL INFORMATION FROM THE REPORTER STATED THE KEYPAD HAD INTERMITTENT FUNCTION/OUTPUT. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING,'KEYPAD NOT WORKING INTERMITTENTLY' WAS NOT REPRODUCED. THE INCOMING TESTING WAS REVIEWED AND FOUND THAT THE KEYPAD PASSED TESTING. 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 REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A DAMAGED KEYPAD. THE KEYPAD REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. 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 KEYPAD WASN'T WORKING DURING PROGRAMMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589296 SPECTRUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 3570009 NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown