BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL PXL8V2 LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUS

    MDR report key: 109234 · Received July 30, 1997

    Report

    Report Number
    2432733-1997-00033
    Event Type
    Other
    Date Received
    July 30, 1997
    Date of Event
    June 30, 1997
    Report Date
    July 1, 1997
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESPONSIBLE PHYSICIAN DECLINED TO PROVIDE FUTHER INFO REGARDING THE EVENT, BEYOND GENERAL SYMPTOMATOLGY, WHICH WAS INITIALLY DESCRIBED. IN THE ABSENCE OF SUCH INFO, FURTHER ANALYSIS IS NOT POSSIBLE. THE USER NEITHER RETAINED THE DEVICE, NOR RECORDED ITS LOT NUMBER, AS SUCH, A REVIEW OF THE LOT MFG HISTORY COULD NOT BE CONDUCTED. THE NATURE OF THE EVENT, AND ANY POSSIBLE RELATION TO THE DEVICE IN USE, ARE INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT URTICURIA, HYPOTENSION AND INDISTINCT CONSCIONESS OCCURRED AFTER A PC TRANSFUSION THROUGH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL PXL8V2 LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUS LEUKOCYTE REDUCTION FILTER FOR PLATELETS CAK PALL BIOMEDICAL PRODUCTS CO. PXL8V2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other