BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA MODEL SPECTRUM

    MDR report key: 1937796 · Received December 22, 2010

    Report

    Report Number
    1314492-2010-00029
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 23, 2010
    Manufacturer
    SIGMA LLC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL PENDING RETURN TO SIGMA.

    Description of Event or Problem · 1

    AFTER INFUSING A MAGNESIUM SULFATE IVPB, THE RN FOUND BLOOD UP INTO THE TUBING AND UP INTO THE BURETROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL SPECTRUM SPECTRUM INFUSION PUMP FRN SIGMA LLC. 35700 757993

    Patients

    Seq Age Sex Outcome Treatment
    1