BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 5704328 · Received June 7, 2016

    Report

    Report Number
    9616066-2016-00765
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    May 21, 2016
    Report Date
    May 24, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE LOGS/DEVICE/PRODUCT BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BAXTER 1000ML IV BAG OF 10MEQ/L KCL IN 5% DEXTROSE AND 0.45% NACL, LOT Y011015, EXP: 08/2017; BAXTER 25ML IV BAG OF 0.9% NACL, LOT P346130, EXP: 11/2016, THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT OF SECONDARY INFUSED INTO THE PRIMARY WAS CONFIRMED. NO ANOMALIES WERE OBSERVED ON THE PRIMARY AND SECONDARY SETS DURING VISUAL INSPECTION. THE CHECK VALVE WAS VISUALLY INSPECTED UNDER MAGNIFICATION AND WAS NOTED TO BE ASSEMBLED IN THE SET CORRECTLY, AND THE SILICONE MEMBRANE WAS CENTERED. DURING FUNCTIONAL TESTING FLUID AND AIR BUBBLES WERE OBSERVED GOING PAST THE CHECK VALVE INTO THE PRIMARY BAG, INDICATING A FAULTY CHECK VALVE. DISASSEMBLY OF THE CHECK VALVE PART RESULTED IN DISCOVERY OF A 0.0318¿ LONG PARTICLE LOCATED BETWEEN THE HOUSING SEAL AREA AND THE AFFIXED SILICONE DIAPHRAGM DISK. THE PARTICLE WAS IDENTIFIED AS ACRYLONITRILE BUTADIENTE STYRENE. THE ROOT CAUSE OF THE CHECK VALVE FAILURE IS DUE TO AN ACRYLONITRILE BUTADIENTE STYRENE PARTICLE FOUND IN THE FLUID PATH THAT PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE ORIGIN OF THE ACRYLONITRILE BUTADIENTE STYRENE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PRIMARY IV D51/2 NACL + KCL10MEQ/L AT 250ML. HR. WAS INFUSING. THE USER HUNG THE SECONDARY IV MESNA TO INFUSE AT 120 ML PER HR. AS THE USER UNCLAMPED THE SECONDARY TUBING IT WAS NOTED TO BE DRIPPING RAPIDLY. THE SECONDARY WAS CLAMPED AND REASSESSED THE CONNECTION AND PUMP RATE. THE USER ATTEMPTED TO UNCLAMP THE SECONDARY TUBING AGAIN AND IT APPEARED THAT THE BAG WAS DRIPPING FREELY AND NOTICED THE SECONDARY BAG WAS EMPTIED. THE INFUSION WAS STOPPED AND CHANGE THE DEVICE AND NEW TUBING AND RE DOSED WITH ADDITIONAL DOSE OF MESNA. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357348 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR