BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM WITH MDL

    MDR report key: 20742651 · Received November 21, 2024

    Report

    Report Number
    1314492-2024-03588
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 21, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FRN
    UDI-DI
    00085412091570
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS ENTREGAR EN ALMACEN CARR NO 2 KM 157 AVE HOSTOS NO 410 THE DEVICE WAS RECEIVED FOR EVALUATION. DURING EVALUATION OF A RETURNED SPECTRUM PUMP, THE DEVICE ALARMED SYSTEM ERROR 345 (THERMISTOR DISPARITY). A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE WAS IDENTIFIED TO BE FORCE SENSOR WHICH REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING EVALUATION OF A RETURNED SPECTRUM PUMP, THE DEVICE ALARMED SYSTEM ERROR 345 (THERMISTOR DISPARITY). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460763 SPECTRUM WITH MDL PUMP, INFUSION FRN BAXTER INTERNATIONAL INC. 35700BAX NA 00085412091570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown