BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3853323 · Received January 23, 2014

    Report

    Report Number
    1314492-2014-04466
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 30, 2013
    Report Date
    December 30, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE EVAL CONFIRMED AND REPRODUCED THE "DOWNSTREAM OCCLUSION" ALARM FOUND DURING EVAL AND THE CAUSE WAS DETERMINED TO BE AN ELEVATED DOWNSTREAM SENSOR CURRENT READING. THE PUMP WAS RE-CALIBRATED TO ENSURE PROPER DOWNSTREAM OCCLUSION DETECTION.

    Description of Event or Problem · 1

    DURING BAXTER'S DEVICE EVAL, THE DEVICE DISPLAYED A "DOWNSTREAM OCCLUSION" ALARM WHEN NO OCCLUSION WAS PRESENT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55368 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1