BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL PXLS LEUKOCYTE REDUCTION FILTER FOR PLATELETS TRANSFUSI

    MDR report key: 116177 · Received August 29, 1997

    Report

    Report Number
    2432733-1997-00039
    Event Type
    Other
    Date Received
    August 29, 1997
    Date of Event
    March 1, 1996
    Report Date
    July 27, 1997
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYMPTOMS OF THE REACTION DESCRIBED COINCIDE WITH MANY OF THOSE KNOWN TO BE ASSOCIATED WITH ANAPHYLACTOID OR IMMEDIATE GENERALIZED REACTION. IMMEDIATE GENERALIZED REACTIONS HAVE BEEN ASSOCIATED WITH PT SENSITIVITY TO THE PLASMA CONSTITUENTS WHICH ACCOMPANY THE PLATELETS DURING INFUSION, IN SUCH PLATELET PREPARATIONS AS CONTAIN PLASMA. IT HAS BEEN REPORTED BY BUCK, ET AL THAT WASHING OF PLATELETS WOULD PREVENT SOME ALLERGIC, BUT NOT FEBRILE, REACTIONS. A REVIEW OF THE LOT MFG HISTORY OR FIELD HISTORY WAS NOT POSSIBLE AS THE DEVICE WAS NEITHER RETAINED NOR IT'S LOT NUMBER RECORDED. IT IS CONCLUDED THAT THE EPISODE REPORTED WAS MOST LIKELY RELATED TO MEDICATIONS EMPLOYED AND/OR THE NATURE OF THE BLOOD PRODUCTS BEING TRANSFUSED TO THIS PT, OR TO UNIDENTIFIED PREDISPOSING FACTORS IN THE PTS IN CONJUNCTION WITH ANY OF THE PRECEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDIATRIC PT EXPERIENCED SEVERE HYPOTENSION. PT'S 02 SATS DECREASED FROM 60'S TO 20'S. THE PT WAS TRANSFUSED POST NORWOOD (CARDIAC SURGERY). IT WAS STATED THAT THE PT WAS VERY SICK AND THAT THE REPORTED HYPOTENSION COULD HAVE CONTRIBUTED TO THE PT'S DEMISE 14 DAYS LATER. THE REPORTER COULD NOT IDENTIFY WHICH OF SEVERAL VARIABLES MIGHT HAVE CAUSED THE HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL PXLS LEUKOCYTE REDUCTION FILTER FOR PLATELETS TRANSFUSI LEUKOCYTE REDUCTION FILTER FOR PLATELETS CAK PALL BIOMEDICAL PRODUCTS CO. PXL8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening