BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL EBDS

    MDR report key: 3984613 · Received August 4, 2014

    Report

    Report Number
    1219343-2014-00022
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 23, 2014
    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 06/03/2014 AT THE REPORTING FACILITY WAS SAMPLED AND STORED APPROPRIATELY ACCORDING TO THE FACILITY PROTOCOLS. THE UNIT PASSED BACTERIAL TESTING USING THE EBDS. THE PLATELET UNIT WAS TESTED AT THE HOSPITAL AFTER THE TRANSFUSION REACTION AND WAS POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS AND STAPHYLOCOCCUS HOMINIS. THE EBDS DOES NOT DETECT STAPHYLOCOCCUS HOMINIS. THE DEVICE IS NOT BEING RETURNED. THE PLATELET SAMPLE WAS RETURNED TO THE MANUFACTURING SITE. RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE RESULTS BECOME AVAILABLE. (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 TRANSFUSED ONE UNIT OF PLATELETS TO A PATIENT RECEIVING CHEMOTHERAPY FOR ACUTE MYELOID LEUKEMIA. THE COLLECTED PLATELET UNIT HAD BEEN TESTED AT THE COLLECTION SITE FOR BACTERIAL CONTAMINATION USING THE EBDS DEVICE. THE TEST DID NOT DETECT BACTERIAL GROWTH. NO TESTING WAS DONE AT THE HOSPITAL PRIOR TO TRANSFUSION. THE TRANSFUSION RESULTED IN A REACTION WITH A RASH, PRURITUS, FLUSHING CHILLS AND NAUSEA. THE TRANSFUSION WAS TERMINATED AS SOON AS THE REACTION WAS EVIDENT. THE PATIENT RECEIVED BENADRYL AND ATIVAN. THE SYMPTOMS SUBSIDED WITH THE ADMINISTRATION OF THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455249 PALL EBDS MZC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization