BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL EBDS

    MDR report key: 3554507 · Received January 6, 2014

    Report

    Report Number
    1219343-2013-00071
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    November 26, 2013
    Report Date
    November 26, 2013
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    MZC
    PMA / PMN Number
    BK070063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATELET UNIT COLLECTED ON (B)(6) 2013, AT THE REPORTING FACILITY WAS SAMPLED AFTER 24 HOURS HOLD AND AFTER 18 HOUR STORAGE AT 20-24 DEGREES CELSIUS. THE UNIT PASSED USING THE EBDS. THE UNIT WAS SPLIT INTO TWO PLATELET UNITS AND BOTH SENT TO SEPARATE HOSPITAL LOCATIONS FOR TRANSFUSION. THE REPORTED TRANSFUSION REACTION WAS FROM THE PLATELET UNIT THAT TESTED POSITIVE AT THE HOSPITAL LAB FOR STREPTOCOCCUS VIRIDANS. A BLOOD CULTURE FROM THE TRANSFUSION RECIPIENT ALSO GREW A CULTURE FOR STREPTOCOCCUS VIRIDANS. THIS RESULTED IN A TRANSFUSION REACTION WITH HOSPITALIZATION. IT IS UNK AT THAT POINT THE BACTERIA GREW AS THE EBDS TESTING WAS PERFORMED PRIOR TO THE UNIT BEING SPLIT. THE SECOND UNIT WAS TRANSFUSED WITH NO REPORTS OF BACTERIAL GROWTH OR ANY REACTION. THE DEVICE IS NOT BEING RETURNED. THERE ARE NO SIMILAR INSTANCES REPORTED FOR THE SAMPLING POUCH COMPONENT. THE REPORTING FACILITY STATES THE COLLECTED UNIT WAS STORED AND TESTED APPROPRIATELY. (B)(4).

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT THAT THE PALL ENHANCED BACTERIAL DETECTION SYSTEM (PALL EBDS) RETURNED A FALSE NEGATIVE RESULT WHICH RESULTED IN A TRANSFUSION REACTION. IT WAS REPORTED TO HAEMONETICS THAT A HOSPITAL END-USER HAD CULTURED A TWO PLATELET UNIT THAT WAS COLLECTED AND SPLIT THE COLLECTION SITE FROM (B)(6) 2013. THE COLLECTED PLATELET UNIT HAD BEEN TESTED AT THE COLLECTION SITE FROM BACTERIAL CONTAMINATION USING THE DEVICE PRIOR TO SPLITTING AND RECEIVED A PASS. THE HOSPITAL CULTURE ON ONE OF THE SPLIT UNITS GREW STREPTOCOCCUS VIRIDANS, BUT THE RESULTS OF THAT CULTURE WERE NOT AVAILABLE PRIOR TO THE HOSPITAL TRANSFUSING THE ONE PLATELET UNIT. THE UNIT WAS TRANSFUSED INTO A (B)(6) YEAR OLD MALE OUTPATIENT. THE TRANSFUSION RESULTED IN A REACTION WITH FEVER AND TRANSFUSION LETHARGY. THE RECIPIENT THEN WAS ADMITTED INTO THE HOSPITAL FOR SEVEN DAYS OF ANTIBIOTIC TREATMENT. THE SECOND SPLIT UNIT WAS SENT TO A SEPARATE FACILITY AND TRANSFUSED ON (B)(6) 2013 WITH NO REPORT OF BACTERIAL CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6818 PALL EBDS MZC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization