BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 3893487 · Received June 13, 2014

    Report

    Report Number
    3893487
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S IV PUMP WITH HEPARIN GTT WAS BEEPING. INDICATED "SYSTEM ERROR 322" ON THE PUMP. IV PUMP WAS REPLACED. NO APPARENT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351400 SIGMA SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORP. 35700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR