BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINSTRATION SET

    MDR report key: 4214039 · Received August 14, 2014

    Report

    Report Number
    9616066-2014-00828
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Report Date
    July 30, 2014
    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

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF ETOPOSIDE "AT THE FIRST CIRCLE ON THE FILTER." THE SET WAS PRIMED BY THE PHARMACY AND NO LEAKING WAS NOTED. WHEN THE INFUSION WAS STARTED THE PT NOTICED ETOPOSIDE LEAKING FROM THE FILTER WITHIN THE FIRST FEW MINS. THE TUBING SET UP WAS CHANGED TO A LOW SORBING SET WITH AN ADD-ON FILTER AND ADD-ON TEXIUM. THE INFUSION COMPLETED WITH NO FURTHER ISSUES. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487104 ALARIS PUMP MODULE ADMINSTRATION SET IV INFUSION SET FPA CAREFUSION CORP 2465-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR