BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL RCXL1 LEUKOCYTE REDUCTION FILTER FOR RED CELL TRANSFUSN

    MDR report key: 72175 · Received March 3, 1997

    Report

    Report Number
    2432733-1997-00008
    Event Type
    Other
    Date Received
    March 3, 1997
    Report Date
    February 4, 1997
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYMPTOM OF HYPOTENSION DURING TRANSFUSION USING THE DEVICE APPEARS LIMITED TO A SMALL COHORT OF CONDITIONS, ALL OF WHICH CAUSE VASCULAR INSTABILITY IN THE PATIENT 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, TRANSFUSION THROUGH CENTRAL LINES, AND USE OF MEDICATIONS THAT RESULT IN VASCULAR INSTABILITY, ESPECIALLY ANGIOTENSIN CONVERTING ENZYME INHIBITORS, AND RAPID TRANSFUSION FLOW RATES. IN THIS SPECIFIC CASE, THE CONDITIONS INVOLVED WERE: HEMODIALYSIS, USE OF MEDICATIONS KNOWN TO PRODUCE VASCULAR INSTABILITY (ANGIOTENSIN CONVERTING ENZYME INHIBITORS), AND RAPID FLOW RATES. THESE CONDITIONS PER SE DO NOT RESULT IN PRECIPITOUS HYPOTENSIVE REACTION. IT APPEARS THAT SOME VARIABLE IN THE BLOOD COMPONENT TRANSFUSED, AS WELL AS UNIDENTIFIED IDIOPATHIC FACTOR IN THE PATIENT, MUST ALSO BE PRESENT. IT IS UNCLEAR AS TO WHETHER WHEN THE PRECEDING CONDITIONS AND/OR PRACTICES EXIST IN THE PROPER CONFIGURATIONS, WHETHER THE DEVICE ALSO PLAYS A CONTRIBUTING ROLE IN THE REACTION OBSERVED. THE DEVICE HAS BEEN USED FOR MULTIPLE THOUSANDS OF TRANSFUSIONS (IN THE ABSENCE/AND PRESENCE OF THE ABOVE CONDITIONS), WITHOUT INCIDENCE OF HYPOTENSION REACTIONS. THERE HAS BEEN NO CORRECLATION BETWEEN MFG LOTS AND THESE REACTIONS. NEITHER THE LOT NUMBER, NOR THE DEVICE WAS RETURNED, ACCORDINGLY, A REVIEW OF THE MFG HISTORY OF THE DEVICE WAS NOT POSSIBLE. THIS CATEGORY OF REACTIONS APPEARS LIMITED TO A SMALL NUMBER OF HEALTH CARE FACILITIES. ALTHOUGH THESE REACTIONS COULD BE CONSISTENT WITH THE PRESENCE OF A SHORT-LIVED BIOLOGICAL MODIFIER, NO EVIDENCE OF SUCH A MODIFIER HAS BEEN CONFIRMED IN THESE INSTANCES. THE SPECIFIC CAUSE OF THIS LOW FREQUENCY HYPOTENSIVE REACTION REMAINS UNIDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE DIAGNOSED WITH DIABETIC NEPHROPATHY, WAS BEING TRANSFUSED THROUGH THE DEVICE AND EXPERIENCED HYPOTENSION AND NAUSEA. THE PT'S BLOOD PRESSURE DECREASED FROM 150/70MMHG TO 89/70MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL RCXL1 LEUKOCYTE REDUCTION FILTER FOR RED CELL TRANSFUSN LEUKOCYTE REDUCTION FILTER FOR RED CELL TRANSFUSION CAK PALL BIOMEDICAL PRODUCTS CO. RCXL1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R