BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER INTERNATIONAL INC

    MDR report key: 19431343 · Received May 30, 2024

    Report

    Report Number
    1314492-2024-01617
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION D1, D3 DEVICE MANUFACTURER NAME, D4: MODEL #, D4UNIQUE IDENTIFIER (UDI) #, G4. ADDITIONAL INFORMATION: D9, H3, H6, H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING , '2ND & 4TH BUTTON TOP ROW DEFECTIVE' WAS REPRODUCED. 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 OVERLAY. 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 INFUSION PUMP'S 2ND & 4TH BUTTON ON THE TOP ROW WERE DEFECTIVE. 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
    330845 BAXTER INTERNATIONAL INC PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 3570009 NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown