BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3112587 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12333
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION:THE USE ERROR, WHICH CONTRIBUTED TO THE REPORTED OVER INFUSION, WAS A RESULT OF NOT CLOSING THE KEYED SLIDE CLAMP ON THE ADMINISTRATION SET PRIOR TO INSERTING IT INTO THE PUMP. PROPER USER INSTRUCTIONS ARE ADDRESSED IN OPERATOR'S MANUAL FOR THE PUMP. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY LOADING THE ADMINISTRATION SET. A LABELING REVIEW FOR THE PRODUCT FAMILY WILL BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION INFORMATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, USE ERROR WAS IDENTIFIED TO HAVE CONTIBUTED TO THE REPORTED CONDITION.SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN A FLO-GARD IV SOLUTION ADMINISTRATION SET WAS OBSERVED TO FREEFLOW. THE PHYSIOLOGIST SET UP THE COLLEAGUE INFUSION PUMP FOR A DOBUTAMINE STRESS ECHO. THE PUMP WAS PROGRAMMED TO INFUSE 100 ML AT 24 ML/HR. THE SET WAS THEN LOADED INTO THE PUMP WITH THE ROLLER CLAMP SHUT AND THE BLUE SLIDE CLAMP OPEN. THE LINE WAS CONNECTED TO THE PATIENT, THE ROLLER CLAMP WAS OPENED AND THE INFUSION WAS STARTED. WITHIN 30 SECONDS THE PATIENT'S HEART RATE HAD RISEN TO 149 BPM. A SECOND PHYSIOLOGIST NOTICED IN THE DRIP CHAMBER THAT THE INFUSION WAS FREE FLOWING. THE SECOND PHYSIOLOGIST PRESSED THE "STOP" BUTTON BUT IT DID NOT WORK, SHE THEN CLOSED THE ROLLER CLAMP STOPPING THE FREE FLOW. THERE WAS NO REPORT OF A SERIOUS INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212196 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1 COLLEAGUE SINGLE CHANNEL MONOCHROME PUMP| DOBUTAMINE