BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA 8000+

    MDR report key: 597596 · Received April 29, 2005

    Report

    Report Number
    1314492-2005-00003
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2005 PT WAS SET FOR AN INFUSION OF 1000MLS OF SALINE SOLUTION OR RINGER'S LOCTATE AT A RATE OF 99MLS/HR. WITHIN 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+ GENERAL PURPOSE INFUSION PUMP FRN SIGMA INTL. 8000+ *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other