BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA MODEL 8000+

    MDR report key: 643413 · Received October 25, 2005

    Report

    Report Number
    1314492-2005-00005
    Event Type
    Other
    Date Received
    October 25, 2005
    Date of Event
    September 22, 2005
    Report Date
    October 24, 2005
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN 2005 A HEPARIN DRIP AT 12ML/HR BEGAN AT APPROXIMATELY 13:25 CTZ. AT APPROXIMATELY 15 :33 CTZ A USER BECAME AWARE OF THE OVER-INFUSION. THERE WAS NO PATIENT INJURY PER HOSPITAL RISK MANAGER. A PRECAUTIONARY HEPARIN ANTIDOTE WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL 8000+ GENERAL PURPOSE INFUSION PUMP FRN SIGMA INTL. 8000+ *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention