BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP

    MDR report key: 1354162 · Received March 31, 2009

    Report

    Report Number
    6000001-2009-00275
    Event Type
    Malfunction
    Date Received
    March 31, 2009
    Date of Event
    March 10, 2009
    Report Date
    March 12, 2009
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    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 EVAL. THE CUSTOMER RETURNED THE DEVICE TO THEIR FACILITY BIO-MED DEPARTMENT FOR TESTING IMMEDIATELY FOLLOWING THE REPORTED INCIDENT AND DETERMINED THAT THE DEVICE FUNCTIONED AS INTENDED. THE CUSTOMER STATED THE DEVICE WILL NOT BE RETURNED TO BAXTER FOR EVAL. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NURSE SPIKED THE MINI-BAG AND PROGRAMMED THE FLO-GARD INFUSION PUMP. SERIAL NUMBER UNK, TO HAVE THE BAG RUN DRY. THEY DO THIS BY PROGRAMMING THE VTBI (VOLUME TO BE INFUSED) TO BE GREATER THAN THE AMOUNT OF SOLUTION THE BAG. WHEN THE PUMP COMPLETED THE INFUSION AND RAN THE BAG DRY, THE NURSE EITHER DISCOVERED OR WAS ALERTED BY THE PT'S FAMILY MEMBER TO THE EMPTY BAG. THE BAG AND UPSTREAM TUBING WAS FOUND EMPTY. FLUID IS STILL PRESENT IN THE DOWNSTREAM TUBING AND APPEARS TO BE "PULSATING". BLOOD WAS ALSO PULSATING AT THE PT 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 AND DOES NOT RETRACT AS EXPECTED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THIS CONDITION OCCURRED WHILE ADMINISTERING FAMOTIDINE TO A PT FROM THE 50ML MINI-BAG VIAFLEX, PRODUCT, LOT NUMBER P222414, 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 INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1