BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1354153 · Received March 31, 2009

    Report

    Report Number
    6000001-2009-00269
    Event Type
    Malfunction
    Date Received
    March 31, 2009
    Date of Event
    March 18, 2009
    Report Date
    March 26, 2009
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER HAS NOT RECEIVED THE DEVICE FOR EVALUATION. THE CUSTOMER STATED THE DEVICE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FIELD IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NURSE SPIKED THE MINI-BAG AND PROGRAMMED THE FLO-GARD INFUSION PUMP, TO HAVE THE BAG RUN DRY. WHEN THE PUMP COMPLETED THE INFUSION AND RAN THE BAG DRY, THE NURSE EITHER DISCOVERED OR WAS ALERTED BY THE PATIENT'S FAMILY MEMBER TO THE EMPTY BAG. THE BAG AND UPSTREAM TUBING WERE FOUND EMPTY. FLUID IS STILL PRESENT IN THE DOWNSTREAM TUBING AND APPEARS TO BE "PULSATING". BLOOD IS ALSO PULSATING AT THE PATIENT IV SITE. THE PUMP DID NOT ALARM AT THIS POINT. THE NURSE REMOVED THE TUBING FROM THE PUMP AND DISCOVERED THE TUBING IS EMPTY AND FLAT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THIS CONDITION OCCURRED WHILE ADMINISTERING DEXAMETHASONE TO A PATIENT FROM THE 50ML MINI-BAG VIAFLEX, PRODUCT LOT NUMBER P232405, IN 2009. THE CUSTOMER BELIEVES THIS ISSUE IS RELATED TO USE OF THIS 50ML MINI-BAG SINCE THEY BEGAN EXPERIENCING THIS ISSUE UPON INTRODUCING THIS PRODUCT INTO THEIR PROCESS. THIS CONDITION ONLY OCCURS WITH MINI-BAGS THAT ARE NOT PRE-PRIMED BY THE PHARMACY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE 80FRN FRN BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1