BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE SPINNING SPIROS, CLOSED MALE CONNNECTOR

    MDR report key: 1832194 · Received September 4, 2010

    Report

    Report Number
    MW5017343
    Event Type
    Malfunction
    Date Received
    September 4, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 4, 2010
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN USING A CHEMOTHERAPY PREPARATION AND INFUSION PRODUCT FROM ICU MEDICAL CALLED THE CLAVE SINCE (B)(6) 2010. WE HAVE EXPERIENCED A MAJOR PROBLEM WITH THE DEVICE OVER THIS TIME WHICH STARTED VERY EARLY ON. THE COMPANY INFORMED US THAT THE PROBLEM WAS SPECIFICALLY WITH THE "SPINNING SPIROS, CLOSED MALE CONNECTOR" PART OF THE PRODUCT. THE DEVICE WAS CAUSING SMALL, PLASTIC, "GRAIN OF SAND SIZE" PARTICLES TO BREAK OFF AND POTENTIALLY ENTER THE INFUSION TUBING DURING CHEMOTHERAPY PREPARATION. WHEN THIS ISSUE WAS FIRST BROUGHT TO ICU MEDICAL'S ATTENTION, THE COMPANY INFORMED US THAT THE PROBLEM WOULD BE CORRECTED SINCE WE WERE USING SOME OLD "BAD" LOT NUMBERS. THEY CAME IN AND CHANGED OUT OUR STOCK WITH SOME "GOOD" LOT NUMBERS OF THE PRODUCT AND TOOK AWAY ALL OF THE OLD LOTS. OVER THE COURSE OF THE NEXT SEVERAL WEEKS WE NOTICED THE SAME PROBLEM OCCURRING WITH THE PRODUCT. THIS SMALL PLASTIC PARTICULATE WAS SHOWING UP AGAIN WHICH COULD CAUSE SERIOUS HARM TO THE PATIENT IF IT ENTERED THE BLOODSTREAM. (B)(4). THE REPRESENTATIVES FROM ICU MEDICAL WERE NOT HELPFUL IN GETTING THE ISSUE RESOLVED OR GIVING US INFORMATION THAT EXPLAINED WHAT HAPPENED. THEY CREATED A SENSE OF FRUSTRATION AMONGST THE NURSING AND PHARMACY STAFF AND MANAGEMENT. WE SUBSEQUENTLY PULLED THE PRODUCT FROM USE AT OUR INSTITUTION AND ASKED THE COMPANY REPRESENTATIVES TO NOT CONTACT US UNLESS WE DECIDED TO CONTACT THEM. THE "BAD" LOT NUMBERS OF THE "SPINNING SPIROS" -PART #20130-01- THAT ICU MEDICAL PROVIDED TO US VIA EMAIL OVER THE COURSE OF THIS ISSUE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE SPINNING SPIROS, CLOSED MALE CONNNECTOR CLAVE SPIROS FPA ICU MEDICAL 78857YJ
    2 CLAVE SPINNING SPIROS, CLOSED MALE CONNECTOR CLAVE SPIROS FPA ICU MEDICAL 1844961
    3 CLAVE SPINNING SPIROS, CLOSED MALE CONNECTOR CLAVE SPIROS FPA ICU MEDICAL 1851152
    4 CLAVE SPINNING SPIROS, CLOSED MALE CONNECTOR CLAVE SPIROS FPA ICU MEDICAL 78867YJ
    5 CLAVE SPINNING SPIROS, CLOSED MALE CONNECTOR CLAVE SPIROS FPA ICU MEDICAL 824392A

    Patients

    Seq Age Sex Outcome Treatment
    1