BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA

    MDR report key: 721787 · Received April 27, 2006

    Report

    Report Number
    721787
    Event Type
    Other
    Date Received
    April 27, 2006
    Date of Event
    March 24, 2006
    Report Date
    April 25, 2006
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS STATUS POST HEART TRANSPLANT AND WAS IN-HOUSE FOR TREATMENT OF ORGAN REJECTION. A PLASMAPHERESIS CATHETER WAS PLACED AND THE 1ST ROUND OF PLASMAPHERESIS WAS RUN. NEAR THE END OF THE RUN, THE NURSE NOTICED THAT A CLAMP HAD NOT BEEN RELEASED, AND EXCESS FLUID WAS NOT EXCHANGED PER PROTOCOL. THE PATIENT WAS NOT HARMED BY THIS INCIDENT. WE HAVE EXPERIENCED THE WASTE BAG BEING ACCIDENTALLY CLAMPED THREE TIMES IN THE LAST SIX MONTHS. THERE ARE NO INSTRUCTIONS TO CLAMP THE BAG UNTIL THE VERY END OF THE PROCEDURE BY THE MANUFACTURER OR IN OUR OWN STANDARD OPERATING PROCEDURE. IN DISCUSSING THE SITUATION WITH THE MANUFACTURER, THE MEDICAL PERSONNEL AND GAMBRO AGREE THAT THE CLAMPS WERE LIKELY PLACED DURING THE MANUFACTURING OR PACKAGING OF THE KIT. THE MANUFACTURER SUGGESTED REMOVING THE CLAMPS FROM THE WASTE BAG LINE, WHICH HAS BEEN DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA PLASMAPHERESIS LKN GAMBRO BCT, INC. * *
    2 * WASTE BAG, APHERESIS LKN GAMBRO BCT, INC. * 02M15213

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR