BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 11890422 · Received May 26, 2021

    Report

    Report Number
    1314492-2021-01947
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: E1: INITIAL REPORTER ADDRESS LINE 1: (B)(6). G4: PMA/510K# UPDATED TO K133801. ADDITIONAL INFORMATION: H10: A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, AND AN EVALUATION IS COMPLETE. EVALUATION INCLUDED A VISUAL ASSESSMENT AS WELL AS FUNCTIONAL TESTING. EVALUATION EXPERIENCED A SYSTEM ERROR 345 DURING TESTING. THE CAUSE WAS IDENTIFIED TO BE A FAILED UPSTREAM THERMISTOR AND THE UPSTREAM SENSOR ASSEMBLY WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED SPECTRUM INFUSION 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
    780963 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1