BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECELL TISSUE CULTURE BAG 1000ML

    MDR report key: 588039 · Received March 29, 2005

    Report

    Report Number
    6000001-2005-00745
    Event Type
    Malfunction
    Date Received
    March 29, 2005
    Date of Event
    March 6, 2005
    Report Date
    March 8, 2005
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RECEIVED REPORT FROM SENIOR RESEARCHER AT FACILITY IN 03/2005 OF LIFECELL BAG THAT "BROKE" DURING TRANSPLANT PROCEDURE IN 2005. PATIENT WAS RECEIVING TRANSPLANT OF ISLET CELLS (SOLUTION) AND THERE WAS A LOSS OF APPROXIMATELY 15-20ML OF PRODUCT, BUT PATIENT RECEIVED THE REMAINING AMOUNT IN THE BAG. THERE WAS NOT MORE THAN 250ML OF PRODUCT IN THE BAG. THERE IS NO AVAILABLE PATIENT INFORMATION OR PATIENT STATUS, BUT THE INITIAL REPORT DENIED ANY PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THERE WAS NO TESTING DONE ON THE BAG AND REPORTER DID NOT KNOW OF TESTING DONE ON THE PATIENT. PROCEDURE WAS PERFORMED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECELL TISSUE CULTURE BAG 1000ML LIFECELL BAGS KJF BAXTER HEALTHCARE CORP. NA H02F24146

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN