BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3853351 · Received January 23, 2014

    Report

    Report Number
    1314492-2014-04465
    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
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE EVAL WAS UNABLE TO REPRODUCE THE UPSTREAM OCCLUSION ALARM DURING ADD'L TESTING AND THE FLUID NUMBERS WERE FOUND TO BE WITHIN SPECIFICATION. HOWEVER, THE UPSTREAM SENSOR WAS REPLACED AS A KNOWN CONTRIBUTOR.

    Description of Event or Problem · 1

    DURING BAXTER'S EVAL A DEVICE ALARMED FOR A FALSE UPSTREAM OCCLUSION. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55365 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1