BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET

    MDR report key: 1136706 · Received August 26, 2008

    Report

    Report Number
    1423500-2008-00772
    Event Type
    Injury
    Date Received
    August 26, 2008
    Date of Event
    June 23, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KSE
    PMA / PMN Number
    BK950048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE NOT AVAILABLE FOR EVAL AS THEY WERE DISCARDED BY THE CUSTOMER. REPORTEDLY, THERE WAS NO VISIBLE PRODUCT DEFECT ON ANY OF THE CRYOCYTE CONTAINERS INVOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED COMPANY TO REPORT AN ADVERSE EVENT THAT OCCURRED WITH A PT WHO RECEIVED BLOOD PRODUCT FROM A CRYOCYTE FREEZING CONTAINER. TRANSFUSION WAS COMMENCED USING A POOLED SAMPLE INCLUDING TWO FROZEN/THAWED CD34 SELECTED PRODUCTS AND FIVE UNITS OF FROZEN/THAWED DONOR ORIGINAL BONE MARROW. TOTAL VOLUME TRANSFUSED WAS 660ML CD34 DOSE WAS 3.67X106/KG. DMSO AMOUNT WAS 1.14G/KG. THE PHYSICIAN INVOLVED DESCRIBED THIS EVENT AS AN ADVERSE REACTION TO STEM CELL INFUSION/DMSO, COMPLICATED BY HYPERTENSIVE CRISIS, SUBARACHNOID HEMORRHAGE, PULMONARY EDEMA, AND ACUTE RENAL IMPAIRMENT HEMOLYSIS. THE PT HAS BEEN STABILIZED BUT HAS A LOW WHITE CELL COUNT AND IS STILL HOSPITALIZED. PER THE ATTACHMENTS OBTAINED FROM MILTENYI BIOTEC INC, THERE WAS NO CRYOCYTE CONTAINER FAILURE, DEFECT OR BREAKAGE INVOLVED WITH THIS INCIDENT. ADD'L INFO RECEIVED ON 08/05/08 PROVIDED A TIMELINE OF THE EVENTS WHICH IS AS FOLLOWS: 1130-INFUSION COMMENCED, THE PT EXPERIENCED CHEST TIGHTNESS, BP 130/80-160/110. ATENOLOL 25MG WAS GIVEN. AT 1400, THE INFUSION WAS COMPLETED. AT 1445, THE PT EXPERIENCED HYPOXIA AND HAD CRACKLES IN THE LEFT MID-ZONE OF THE LUNG. THE BP WAS 220/120. THE BP THEN DROPPED FROM 190/120 TO 160/110. HIGH DOSE OXYGEN SUPPORT WAS GIVEN IN ADDITION TO FUROSEMIDE 40MG IV, AMLODIPINE, AND THEN FUROSEMIDE 40MG IV ONCE AGAIN. AT 1500, THE PT'S URINE WAS BLOOD STAINED. AT 1600, A CHEST X-RAY SHOWED PATCHY INFILTRATION OF BOTH LOWER ZONES OF THE LUNGS. METHYLPREDNISONE WAS GIVEN 1MG/KG. THE PT HAD A MODERATE HEADACHE. A CT OF THE BRAIN SHOWED EXTENSIVE SUBARACHNOID HEMORRHAGE FOR WHICH A PLATELET, RFACTOR VII TRANSFUSION WAS GIVEN. THE PT'S CREATININE WAS 152UMOL/L, THE LDH WAS 4010U/L, AND THE TOTAL BILIRUBIN WAS 109UMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET 81KSE KSE BAXTER HEALTHCARE H07I29029

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R