BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K133801

    MDR report key: 18619408 · Received January 31, 2024

    Report

    Report Number
    1314492-2024-00224
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Report Date
    March 8, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE NO. - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3, H6, H10. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE REPORTED PROBLEM OF "DOOR FULLY LATCHED" WAS 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 VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE THE LOWER AUXILIARY FAILURE. THE LOWER AUXILIARY 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 PUMP ALARMED " DOOR NOT CLOSED". THIS OCCURRED DURING TESTING IN THE BIOMEDICAL DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414705 K133801 PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown