BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2120496 · Received June 8, 2011

    Report

    Report Number
    1314492-2011-00027
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO INFO ON THE PUMP SERIAL# WAS PROVIDED AND THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR INVESTIGATION. IF THE PUMP IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TELEPHONE CONVERSATION THAT ON (B)(6) 2011, THAT AN UNSPECIFIED SIGMA SPECTRUM PUMP CONNECTED TO AN UNSPECIFIED IV TUBING WAS PULLING BLOOD BACK UP INTO THE LINE WHEN IT WAS TRYING TO INFUSE. PER THE HOSP PROJECT MANAGER, THE TWO EVENTS AS DESCRIBED IN REPORTS 1314492-2011-00026 AND 1314492-2011-00027 BOTH OCCURRED THE SAME DAY ON (B)(6) 2011, BOTH INVOLVED THE SAME PT, AND BOTH USER ERRORS WERE BY THE SAME NURSE. AT BOTH TIMES, THE USER WAS REPORTED TO HAVE LOADED THE IV SET BACKWARDS IN THE PUMP WHERE BLOOD WAS ALLEGEDLY DRAWN FROM THE PT AND BACK UP INTO THE BURETROLS. BURETROLS WERE IN USE BOTH TIMES AND THE PUMP WAS SET TO RUN AT A RATE OF 250 ML/HR. THE TUBING WAS CONNECTED VIA A NEWLY PLACED PORTA CATH (BARD TYPE).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1