BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL PXL8V2 LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUS

    MDR report key: 109963 · Received August 1, 1997

    Report

    Report Number
    2432733-1997-00034
    Event Type
    Other
    Date Received
    August 1, 1997
    Date of Event
    July 8, 1997
    Report Date
    July 10, 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

    DEVICE EVAL/ANALYSIS: THE SIGNS AND SYMPTOMS OF THE TRANSFUSION REACTIONS THAT WERE 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 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% TO 10% OF ALL PLATELET POOLS. 2. AN IMMUNOLOGICALLY MEDIATED EVENT. ANALPHYLAXIS HAS BEEN REPORTED AS A RESULT OF THE TRANSFUSION OF HLA INCOMPATIBLE PC TO SENSITIZED RECIPIENT, AND SECONDARY TO THE TRANSFUSION OF SPECIFIC COMPLEMENT 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. 3. INFUSION OF ACTIVATED PLATELETS. ACTIVATED PLATELETS HAVE BEEN ASSOCIATED WITH THE ADULT RESPIRATORY DISTRESS SYNDROME, DYSPNEA, HYPOXIA, AND SHOCK. 4. PREVIOUS ADMINISTRATION OF EMETOGENIC MEDICATION CAN INCREASE THE LEVEL OF RECIPIENT'S SEROTONIN, ADDITIONAL TO THE SEROTONIN LOAD FROM THE TRANSFUSED PLATELETS. THIS HAS THE POTENTIAL FOR SEVERE HYPOTENSIVE EFFECTS. 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. A CYTOKINE INDUCED INFLAMMATORY 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 STORAGE AND STORAGE TIME. 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. 7. IN ONE STUDY OF PLATELET TRANSFUSIONS, 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 PC TRANSFUSIONS OCCUR WITH A NATURAL AND SIGNIFICANT FREQUENCY, AND THAT LEUKODEPLETION DOES NOT INCREASE, BUT MAY IN FACT DECREASE, THE FREQUENCY OF IMMEDIATE GENERALIZED REACTION. 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. THE DECREASE IN BLOOD PRESSURE WAS REPORTED TO BE FROM 100MMHG TO 60MMHG. HEDDLE, ET. AL HAVE REPORTED THAT UP TO 3.6% OF RECIPIENTS OF PT HAVE HYPOTENSIVE EPISODES OF 30MMHG SYSTOLIC/10MM HG DIALSTOLIC OR MORE. THE REACTION WAS TREATED BY ADMINISTRATION OF STEROIDS. IT IS CONCLUDED THAT THE MULTIPLE EPISODES REPORTED WERE 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 PT (THIS PT HAD A STRONG HISTORY OF ALLERGY) IN CONJUNCTION WITH ANY OF THE PRECEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 49 YEAR OLD MALE PT EXPERIENCED HYPOTENSION AND ITCHING 30 MINUTES AFTER THE START OF A PC TRANSFUSION THROUGH THE DEVICE. PT'S BLOOD PRESSURE DECREASED FROM 100 MMHG (NORMAL) TO 60 MMHG. THE TRANSFUSION WAS STOPPED AND STEROIDS WERE ADMINISTERED.

    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 49 YR Required Intervention