BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL PXL8 LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUSIO

    MDR report key: 109967 · Received August 4, 1997

    Report

    Report Number
    2432733-1997-00035
    Event Type
    Other
    Date Received
    August 4, 1997
    Report Date
    July 4, 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

    ANALYSIS: THE SYMPTOMS OF THE TWO TRANSFUSION REACTIONS THAT WERE DESCRIBED COINCIDE WITH MANY OF THOSE KNOWN TO BE ASSOCIATED WITH ALLERGIC AND 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 AL1. THAT WASHING OF PLATELETS WOULD PREVENT SOME ALLERGIC, BUT NOT FEBRILE, REACTIONS. THE CAUSES OF IMMEDIATE GENERALIZED REACTIONS INCLUDE: 1. BACTERIAL AND/OR ENDOTOXIN CONTAMINATION IN ONE OR MORE UNITS OF PC IN THE SEQUENTIAL ADMINISTRATIONS. VARIOUS ESTIMATES HAVE BEEN MADE CONCERNING THE INCIDENCE OF SUCH CONTAMINATION, RANGING FROM 0.05%2 TO 10%3 OF ALL PLATELET POOLS. NO REPORT OF LAB TESTING WHICH MIGHT RATE THIS OUT WAS RECEIVED. 2. AN IMMUNOLOGICALLY MEDIATED EVENT. ANAPHYLAXIS HAS BEEN REPORTED AS A RESULT OF THE TRANSFUSION OF HLA INCOMPATIBLE PC TO SENSITIZED 4RECIPIENT, AND SECONDARY TO THE TRANSFUSION OF SPECIFIC COMPLIMENT DEGRADATION PRODUCTS (I.E., C4D) TO INDIVIDUALS LACKING THE CHIDO AND/OR ROGERS BLOOD GROUP ANTIGENS. FIVE PERCENT OF THE POPULATION IS THEORETICALLY AT RISK FOR THIS PHENOMENON AND IT IS DIRECTLY DEPENDENT ON THE TOTAL QUANTITY OF PLASMA INFUSED.5 3. INFUSION OF ACTIVATED PLATELETS. ACTIVATED PLATELETS HAVE BEEN ASSOCIATED WITH THE ADULT RESPIRATORY DISTRESS SYNDROME, DYSPNEA, HYPOXIA, AND SHOCK.6 4. PREVIOUS ADMINISTRATION OF EMETOGENIC MEDICATION CAN INCREASE THE LEVEL OF RECIPIENT'S SEROTONIN, ADD'L TO THE SEROTONIN LOAD FROM THE TRANSFUSED PLATELETS. THIS HAS THE POTENTIAL FOR SEVERE HYPOTENSIVE EFFECTS.7 IN THE CASE REPORTED, THE PT WAS BEING ADMINISTERED CHEMOTHERAPY, ALTHOUGH THE SPECIFIC AGENTS WERE NOT IDENTIFIED. 5. ETHYLENE OXIDE (ETO) RESIDUALS HAVE BEEN REPORTED TO BE A POTENTIAL SOURCE OF SUCH REACTIONS. THE IMPLICATED DEVICE WAS NOT STERILIZED WITH ETO. 6. A CYTOKINE INDUCED IMFLAMMATORY RESPONSE. IT IS KNOWN THAT CYTOKINES, INCLUDING IL1 AND 6 TNF AND PAF, PROGRESSIVELY ACCUMULATE IN STORED PLATELET CONCENTRATE (PC). LEVELS ARE DIRECTLY RELATED TO WBC CONTENT DURING STORAGE8 AND STORAGE TIME9. SYMPTOMS RESULTING FROM INFUSION OF THESE SUBSTANCES INCLUDED SHOCK, GI DISTURBANCES, VASOMOTOR INSTABILITY, FLUSHING, AND PULMONARY DYSFUNCTION. THESE SYMPTOMS ARE PARTICULARLY LIKELY TO OCCUR IF THE RECIPIENT IS FURTHER CHALLENGED WITH ENDOGENOUS BOLUSES OF ENDOTOXIN.10 7. IN ONE STUDY OF PLATELET TRANSFUSIONS11, AN INCIDENCE OF 5% HYPOTENSIVE REACTIONS WAS OBSERVED WITH PLASMA DEPLETED PC, AND 2% IN LEUKODEPLETED PC WITH A DEVICE MODEL SIMILAR TO THE IMPLICATED DEVICE. 27% OF THESE HYPOTENSIVE REACTIONS HAD COINCIDENT SYMPTOMS OTHER THAN HYPOTENSION. HYPOTENSION IN THIS REPORT WAS DEFINED AS DROP OF MT 30MMHG SYSTOLIC AND 10MMHG DIASTOLIC. IT APPEARS THAT IMMEDIATE GENERALIZED REACTIONS FOLLOWING PPC TRANSFUSIONS OCCUR WITH A NATURAL AND SIGNIFICANT FREQUENCY, AND THAT LEUKODEPLETION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT BEING TRANSFUSED THROUGH THE DEVICE DEVELOPED A HIGH FEVER AND CHILLS ONE HOUR AFTER THE THIRD PC TRANSFUSION. AT THE NEXT PC TRANSFUSION (NEXT DAY) THE PT WAS PRE-MEDICATED WITH HYDROCORTISONE (100 MG). IMMEDIATELY THE PT EXPERIENCED AN ANAPHYLACTOID REACTION, INCLUDING CHILL, SHIVER AND FACIAL FLUSH. THE TRANSFUSION WAS STOPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention