BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3922829 · Received February 5, 2014

    Report

    Report Number
    1314492-2014-06302
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. THE INVESTIGATION HAS NOT BEEN COMPLETED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING BAXTER'S DEVICE EVALUATION, THE DEVICE EXPERIENCED A "SYSTEM ERROR 322" ALARM. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS FOUND DURING EVALUATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74632 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1