BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL LEUKOCYTE REDUCTION FILTER FOR RED CELL TRANSFUSION

    MDR report key: 119106 · Received September 12, 1997

    Report

    Report Number
    2432733-1997-00041
    Event Type
    Injury
    Date Received
    September 12, 1997
    Date of Event
    July 24, 1997
    Report Date
    August 13, 1997
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SYMPTOM OF HYPOTENSION DURING RED CELL TRANSFUSION USING DEVICE APPEARS TO SMALL COHORT OF CONDITIONS, ALL OF WHICH CAUSE VASCULAR INSTABILITY IN THE PT PRIOR TO BEING TRANSFUSED. SUCH CONDITIONS, KNOWN TO GIVE RISE TO VASCULAR INSTABILITY, MAY BE ANY ONE OR SEVERAL OF THE FOLLOWING CIRCUMSTANCES: HEMODIALYSIS, CARDIAC SURGERY, CONGESTIVE HEART FAILURE, TRANSFUSION THROUGH CENTRAL LINES, AND USE OF MEDICATIONS THAT RESULT IN VASCULAR INSTABILITY, ESPECIALLY ANGIOTENSION CONVERTING ENZYME INHIBITORS, AND RAPID TRANSFUSION FLOW RATES. IN THIS SPECIFIC CASE THE CONDITIONS WERE NOT SUBJECT TO VERIFICATION AS THE HEALTH CARE PROFESSIONAL REFUSED THE FIRM'S REQUIRES TO PROVIDE DETAILS OF THE CLINICAL EVENT. THESE CONDITIONS, PER SE, DO NOT RESULT IN PRECIPITOUS HYPOTENSIVE REACTION. IT APPEARS THAT SOME VARIABLE IN THE BLOOD COMPONENT TRANSFUSED, AS WELL AS AN INIDENTIFIED IDIOPATHIC FACTOR IN THE PT, MUST ALSO BE PRESENT. THIS PT HD EXHIBITED HYPOTENSIVE TRANSFUSION REACTIONS ON TWO (2) PREVIOUS OCCASIONS. IN IS UNCLEAR AS TO WHETHER WHEN PRECEDING CONDITIONS AND/OR PRACTICES EXIST IN PROPER CONFIRUGATIONS, WHETHER DEVICE ALSO PLAYS A CONTRIBUTING ROLE IN REACTION OBSERVED. OVERALL DEVICE HAS BEEN USED FOR MULTIPLE THOUSANDS OF TRANSFUSIONS (IN ABSENCE/AND PRESENCE OF ABOVE CONDITIONS), WITHOUT INCIDENCE OF HYPOTENSION REACTIONS. THERE HAS BEEN NO CORRELATION BETWEEN MFG LOTS AND THESE REACTIONS. LOT NUMBER WAS NOT IDENTIFIED BY USER, NOR WAS DEVICE RETAINED. ACCORDINGLY, EVALUATION OF MFG AND FIELD HISTORIES COULD NOT BE ACHEIVED. THIS CATEGORY OF REACTIONS APPEARS LIMITED TO A SMALL NUMBER OF HEALTH CARE FACIITIES. ALTHOUGH THIS REACTION COULD BE CONSISTENT WITH PRESENCE OF A SHORT-LIVED BIOLOGICAL MODIFIER, NO EVIDENCE OF SUCH MODIFIER WAS CONFIRMED IN THIS INSTANCE. FOLLOWINT TRANSFUSION, THERE WAS NO REPORT OF PERMANENT INJURY, ILLNESS OR DEATH. CONCLUSION: SPECIFIC CAUSE OF THIS LOW FREQUENCY HYPOTENSIVE REACTION REMAINS UNIDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT BEING TRANSFUSED THROUGH THE DEVICE EXPERIENCED HYPOTENSION AND REDUCTION OF HEART RATE. THE PT ALSO EXPERIENCED HYPOTENSION TWO PREVIOUS TIMES IN THE SAME CONDITION. IT IS UNK WHAT DEVICES WERE USED DURING THESE TWO PREVIOUS EXPERIENCES OF HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL LEUKOCYTE REDUCTION FILTER FOR RED CELL TRANSFUSION LEUKOCYTE REDUCTION FILTER FOR RED CELL TRANSFUSION CAK PALL BIOMEDICAL PRODUCTS CO. RCXL2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other