BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3942142 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23059
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). BAXTER RECEIVED A PHOTO FOR EVALUATION, HOWEVER THE PHOTO WAS UNCLEAR AND THE REPORTED PROBLEM COULD NOT BE VERIFIED. A RETAINED SAMPLE FROM THE SAME BATCH WAS EVALUATED. VISUAL INSPECTION REVEALED NO NON-CONFORMITIES. THE SET WAS CONNECTED TO A HOUSE BAG AND PRIMED, THEN CONNECTED TO A PUMP AND FUNCTIONALLY TESTED. NO AIR BUBBLES WERE NOTED AND THE SET PERFORMED WITHIN SPECIFICATION. A FLOW RATE TEST WAS PERFORMED FOR 31ML PER HOUR FOR A TOTAL VOLUME OF 100ML; AIR WAS NOT OBSERVED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD IV SOLUTION SET HAD AIR BUBBLES COINCIDENT WITH USE OF A COLLEAGUE TRIPLE CHANNEL PUMP. THE SOLUTION BEING USED WAS A PREMIX KCL, RUNNING AT 65ML PER HOUR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420088 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 14B01V474

    Patients

    Seq Age Sex Outcome Treatment
    1 COLLEAGUE TRIPLE CHANNEL PUMP| PREMIX KCL