BEUDAMED
    FDA Adverse Event Other Summary report: N

    BACT/ALERT BPA AND BPN CULTURE BOTTLES

    MDR report key: 2576515 · Received December 9, 2008

    Report

    Report Number
    3002769706-2008-00009
    Event Type
    Other
    Date Received
    December 9, 2008
    Date of Event
    October 14, 2008
    Report Date
    December 3, 2008
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THIS INCIDENT HAS BEEN INITIATED BY BIOMERIEUX INC. THE COMMUNITY BLOOD CENTER INITIATED A TRANSFUSION REACTION INVESTIGATION ON (B)(6) 2008. THE REPORT STATED THAT "THE IMPLICATED UNIT WAS COLLECTED ON (B)(6) 2008 AND STERILITY SAMPLING WAS PERFORMED ON (B)(6) 2008. THE BACT/ALERT BOTTLES REMAINED NEGATIVE AND WERE REMOVED FROM THE INCUBATOR ON (B)(6) 2008. THE AEROBIC AND ANAEROBIC BOTTLES ALONG WITH THE ASSOCIATED FRESH FROZEN PLASMA UNIT WERE SENT TO THE REFERENCE LAB FOR CULTURES; NO BACTERIAL GROWTH WAS DETECTED." "THE GRAM STAIN AND CULTURE FROM THE PARTIALLY TRANSFUSED PLATELET PRODUCT SHOWED GRAM POSITIVE COCCI AND THE CULTURE GREW (B)(6)." "INVESTIGATION REVEALS THE BACT/ALERT SYSTEM FOR NOTIFICATION WAS FUNCTIONING AND REVIEW BY THE FDA INDICATED THAT ALL STANDARD OPERATING PROCEDURE HAD BEEN FOLLOWED."

    Description of Event or Problem · 1

    A RECIPIENT AT THE (B)(6) IN (B)(6), RECEIVED A PARTIALLY TRANSFUSED PLATELETS PHERESIS UNIT AND EXPERIENCED SEVERE DYSPNEA AND AN ELEVATED TEMPERATURES OF 40 DEGREES C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT BPA AND BPN CULTURE BOTTLES MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 1020387 1020417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other