BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3801746 · Received January 8, 2014

    Report

    Report Number
    1314492-2014-01364
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 11, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER IS CURRENTLY EVALUATING THIS DEVICE. A SUPPLEMENTAL MDR WILL BE SUBMITTED WHEN THE DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE ALARMED FOR A SYSTEM ERROR 322. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12043 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1