BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2619992 · Received June 4, 2012

    Report

    Report Number
    2619992
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Date of Event
    May 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    INFUSION LINE CONNECTED TO PUMP. PUMP INDICATED DRIPS WERE INFUSING. PATIENT BLOOD PRESSURE BEGAN TO DROP. ASSESSED CHAMBER AND NOTICED THAT THERE WERE NO DRIPS INFUSING IN CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM PUMP, INFUSION FRN SIGMA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR