BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL PXL8 LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUSIO

    MDR report key: 116194 · Received August 29, 1997

    Report

    Report Number
    2432733-1997-00037
    Event Type
    Other
    Date Received
    August 29, 1997
    Date of Event
    September 21, 1995
    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. AN INVESTIGATION INTO THE MFG HISTORY OF THE LOT NUMBER (510003) REVEALED THAT THIS LOT WAS MFG IN ACCORDANCE WITH DOCUMENTED PROCEDURES AND MET ALL SPECS REQUIRED FOR RELEASE. NO SIMILAR REPORTS FOR THIS LOT HAVE BEEN REC'D. 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 PULMONARY HYPOTENSION DURING A TRANSFUSION OF IRRADIATED PLATELETS THROUGH THE DEVICE. SYMPTOMS OCCURRED AT 92ML. 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 PXL8 LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUSIO LEUKOCYTE REDUCTION FILTER FOR PLATELETS CAK PALL BIOMEDICAL PRODUCTS CO. PXL8 510003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention