BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 21556698 · Received March 10, 2025

    Report

    Report Number
    1314492-2025-00513
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Report Date
    March 10, 2025
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING EVALUATION, THE REPORTED PROBLEM OF '3 BUTTONS WERE NOT RESPONDING ON A SPECTRUM PUMP, INCLUDING THE DECIMAL BUTTON, NUMBER 4 (ALSO ¿JKL¿ BUTTON) AND NUMBER 5 (ALSO ¿MNO¿ BUTTON)' 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 A FAULTY KEYPAD. THE KEYPAD WILL BE REPLACED TO CORRECT THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BUTTONS WERE NOT RESPONDING ON A SPECTRUM PUMP, INCLUDING THE DECIMAL BUTTON, NUMBER 4 (ALSO ¿JKL¿ BUTTON) AND NUMBER 5 (ALSO ¿MNO¿ BUTTON). 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
    1450864 SIGMA SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 35700BAX2 NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown