BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA 8000+

    MDR report key: 597592 · Received April 29, 2005

    Report

    Report Number
    1314492-2005-00004
    Event Type
    Other
    Date Received
    April 29, 2005
    Date of Event
    March 3, 2005
    Report Date
    April 29, 2005
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2005 AN INFUSION OF 100MLS OF SALINE SOLUTION OR RINGER'S LOCTATE WAS PROGRAMMED AT A RATE OF 999MLS/HR. WITH IN THE HOUR THE PUMP WENT INTO INFUSION COMPLETE ALARM BUT THE BAG WAS STILL FULL. THERE WAS NO PT INJURY. THE INFUSION WAS RESTARTED TO ADMINISTER THE SOLUTION THE PT DID NOT RECEIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other