BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE CULTURE FLASK

    MDR report key: 1413277 · Received July 13, 2009

    Report

    Report Number
    1416980-2009-00036
    Event Type
    Injury
    Date Received
    July 13, 2009
    Date of Event
    June 16, 2009
    Report Date
    July 13, 2009
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KJA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED BY BAXTER ON 06-JULY-2009 OF LAB IN OTHER COUNTRY: "OUR STAFF NOTICED THAT IS WAS VERY TIGHT IN THE TRANSPORTBOX WHEN THE COURIER RETURN TO LAB WITH THE MARROW BAGS. THE BOX SHOULD HAVE HAD A ONE OR TWO EXTRA RINGS. THAT IS TRU. WE WILL DO A ADDITION IN OUR SOP FOR TRANSPORT SO WE DON'T MISS IT MORE WHEN WE PICK UP MARROW. ON THE OTHER HAND WE SAW IN LIFECELLS BAG THAT THE SEALING WHO IS AROUND THE BAG WAS SO NARROW THE EDGE IN THE UPPER CORNER. SO IT IS A MANUFACTURING FAULT. WE HAVE NOT REPORT THE CASE. ONLY OUR OWN INCIDENT REPORTS IN THE QUALITY ASSURANCE." THERE IS NO PRODUCT SAMPLE AVAILABLE, BUT PICTURES WERE RECEIVED. BAXTER MEDICAL ASSESSMENT: THIS IS A REPORTED LEAK FROM A LIFE CELL TISSUE CULTURE BAG THAT WAS DISCOVERED AFTER SHIPMENT AND POOLING OF THE BONE MARROW ASPIRATE. THE RECIPIENT OF THE BM TRANSPLANT DID DEVELOP A REACTION POSSIBLY SEPSIS. HOWEVER, NO BLOOD CULTURE RESULTS ARE REPORTED. IN ALL CASES OF DISRUPTION OF THE CONTAINER BAG, THERE IS THE POTENTIAL OF CONTAMINATION OF THE TRANSPLANT AND RECIPIENT INFECTION AS WELL AS LOSS OF ENGRAFTMENT OR DELAY IN ENGRAFTMENT WITH THE LOSS OF PRODUCT. THIS PUTS THE PATIENT AT GREATER RISK. AS SUCH, A LEAK COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN EVENT IF IT WERE TO REOCCUR. ALL ATTEMPTS SHOULD BE MADE TO OBTAIN RESULTS OF BLOOD CULTURES TO DETERMINE IF POSSIBLE CONTAMINATION OF THE TRANSPLANT HAS OCCURRED. THE PICTURES WILL BE EVALUATED AND A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS AN EVENT REPORT RECEIVED ON 24-JAN-2009 ABOUT ONE UNIT OF LEAKING LIFE CELL TISSUE CULTURE BAG, LOT H08D14062, FROM A HEALTHCARE PROFESSIONAL OF THE LAB IN HOSPITAL. BONE MARROW MATERIAL WAS DONATED ON THE MORNING OF APPROX FIVE MONTHS LATER, FILLED INTO THREE BAGS AND FORWARDED TO STEMCELLS LAB/TISSUE TYPING LAB IN ANOTHER COUNTRY'S HOSPITAL, ARRIVING IN THE LAB THE SAME DAY, RESPECTING THE TRANSPORTATION REQUIREMENTS FOR PRODUCTS OF THIS TYPE. DURING PREPARATION FOR SHIPMENT, NO LEAK WAS DETECTED. THE LAB INFORMED THE REPORTER ABOUT A LEAK DETECTED IN ONE OUT OF THE THREE BAGS PRIOR TO FILTRATION AND REPORTED AS FOLLOWS: "WE GOT THREE BAGS WITH MARROW FROM A DONOR, COLLECTED AT YOUR CENTER THAT MONTH. WHEN WE POOLED THE BAGS TO TAKE SOME SAMPLES, WE FOUND A SMALL SPLIT IN THE UPPER CORNER OF THE BAG WHERE THE SEAL OF THE PLASTIC IS. DURING THE TRANSPORT, IT DIDN'T LEAK. PICTURES ARE TAKEN AND ATTACHED. WE CAN'T SEE ANY LOT ON THE LIFECELL-BAG BUT ON THE LABEL THE "UNIQUE IDENTIFIER" IS PRINTED. THE BAGS ARE SAVED HERE." THE POOLED MARROW FROM ALL THREE BAGS WAS TRANSPLANTED, IT IS CURRENTLY UNKNOWN IF AN ANTIBIOTIC THERAPY WAS ADMINISTERED. ADDITIONAL INFORMATION RECEIVED BY BAXTER ON 29-JUN-2009: PATIENT'S CONDITION AFTER TRANSPLANTATION: SHE HAD DIFFICULTIES TO BREATHE (HYPERVENTILATION). SHE HAS FEVER, AND HIGH CRP 250. SUSPECTED AS TRANSPLANTATION REACTION OR SEPSIS. THEY HAVE NOT RECEIVED THE RESULTS FROM BLOOD CULTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE CULTURE FLASK KJA BAXTER HEALTHCARE H08D14062

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR