BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 1734577 · Received June 18, 2010

    Report

    Report Number
    MW5016466
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 18, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PRODUCT: ICU MEDICAL SPIROS CLOSED MALE CONNECTOR. ICU MEDICAL GENIE CLOSED VIAL ACCESS DEVICE WHEN USING THESE PRODUCTS TOGETHER TO TRANSFER CHEMOTHERAPY PRODUCTS, I HAVE CONSISTENTLY WITNESSED VERY SMALL DROPLETS OF THE CHEMO PRODUCTS FORMING ON THE END OF THE MALE CONNECTOR. AS I DETACH THESE TWO FROM EACH OTHER A SMALL AMOUNT OF THE CHEMO WILL BE RETAINED ON THE END OF THE MALE CONNECTOR. IT IS A VERY SMALL QUANTITY, BUT IT IS THERE CONSISTENTLY. SOMETIMES IT MAY REQUIRE 3-5 TRANSFERS TO DEVELOP BUT BY THE FIFTH DISCONNECT IT NORMALLY FORMS. MOST OF OUR CHEMO PT REQUIRE 60-90ML OF 5-FU IN THEIR CASSETTES. SO, WE HAVE TO ENTER 3-5 VIALS OF 5-FU. AFTER ADDING THE NORMAL SALINE AND THE 5-FU TO THE CASSETTE THE DROPLETS NORMALLY HAVE FORMED. IS THIS ACCEPTABLE WITH A "CLOSED" CHEMO TRANSFER DEVICE? EVENT REAPPEARED AFTER REINTRODUCTION: # 1 & #2 - YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL SPIROS CLOSED MALE CONNECTOR FPA ICU MEDICAL, INC. CH2000 1075878
    2 ICU MEDICAL GENIE CLOSED VIAL ACCESS DEVICE FPA ICU MEDICAL, INC. 1776559

    Patients

    Seq Age Sex Outcome Treatment
    1 Other