BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA AUTOMATED BLOOD COMPONENT COLLECTION

    MDR report key: 289740 · Received August 8, 2000

    Report

    Report Number
    1721028-2000-00001
    Event Type
    Other
    Date Received
    August 8, 2000
    Date of Event
    September 27, 1999
    Report Date
    July 14, 2000
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Removal / Correction Number
    FSB7 (INTERNAL#)
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN PREPARING THE DONOR TUBING, THE OPERATOR FAILED TO CLOSE THE INCH CLAMPS ON THE DONOR NEEDLE AND SAMPLE BAG PER OPERATING INSTRUCTIONS. THE MACHINE ALARMED APPROPRIATELY, HOWEVER, THE OPEN CLAMPS WERE NOT NOTICED AND PREPARATION OF THE TUBING WAS CONTINUED. THE MACHINE ALARMED A SECOND TIME, IN WHICH THE CLAMPS WERE OBSERVED AND CLOSED. THE SAMPLE BAG WAS INFLATED AND WAS NOT EXPELLED PRIOR TO CONNECTING THE DONOR. THE DONOR EXPERIENCED SOME SYMPTOMS, HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. THE DONOR IS REPORTED TO BE FINE. THE EVENT WAS NOT REPORTED TO THE MFR AT THE TIME OF EVENT BECAUSE THE CAUSE OF THE DONOR SYMPTOMS COULD NOT BE IDENTIFIED. IT WASN'T UNTIL A ROUTINE VISIT BY THE MFR THAT LEAD TO A DISCUSSION MENTIONING THE EVENT WHICH RESULTED IN AN INVESTIGATION BY THE MFR TO IDENTIFY A CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA AUTOMATED BLOOD COMPONENT COLLECTION BLOOD COMPONENT COLLECTION SYSTEM LKN GAMBRO BCT, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening