BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3221444 · Received June 28, 2013

    Report

    Report Number
    9616066-2013-00482
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 06/27/2013. INTERNAL FILE NO: (B)(4). THE CUSTOMER'S REPORT THAT THE SECONDARY BACKED UP INTO TH E PRIMARY WAS CONFIRMED. VISUAL INSPECTION IDENTIFIED NO ANOMALIES. FUNCTIONAL TESTING IDENTIFIED A FAULTY CHECK VALVE. SUPPLIER TESTING OF THE COMPONENT REVEALED THE PRESENCE OF A CLEAR PARTICLE, IDENTIFIED TO BE CELLULOSE, BETWEEN THE HOUSING SEAL AND THE DIAPHRAGM. THE CAUSE OF THE CHECK VALVE FAILURE IS DUE TO A CELLULOSE PARTICLE FOUND IN THE FLUID PATH, WHICH PREVENTED THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE ORIGIN OF THE CELLULOSE PARTICLE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A CAREFUSION CLINICAL CONSULTANT REPORTED THAT DURING A TRAINING SESSION DEMONSTRATING THE INFUSION SET UP, FROM THE SECONDARY LINE WHERE SHE WAS SIMULATING AN ANTIBIOTIC SECONDARY INFUSION. THERE WAS NO PT INVOLVEMENT THEREFORE NO PT HARM OR MEDICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295296 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ALARIS SECONDRAY ADMIN SET, MODEL 11448964,| LOT # UNK| B-BRAUN 250ML IV BAG OF 0.9 PERCENT SODIUM CHLORID| REF L8002