BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2201569 · Received August 8, 2011

    Report

    Report Number
    2201569
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING 1 UNIT OF PACKED RED BLOOD CELLS HUNG AT 0400. TOTAL VOLUME WAS 345 ML TO RUN OVER 2 HOURS. AT APPROXIMATELY 0550 RN NOTED BLOOD BAG TO STILL CONTAIN LARGE VOLUME OF BLOOD. TUBING RECHECKED BY RN AND CONFIRMED THAT TUBING AND BAG WERE HUNG CORRECTLY. NOTED TO BE A PUMP PROBLEM. PUMP REMOVED AND BLOOD FINISHED ON NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INFUSION PUMP FRN SIGMA 40111 *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR