BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL

    MDR report key: 227728 · Received June 15, 1999

    Report

    Report Number
    MW1016544
    Event Type
    Injury
    Date Received
    June 15, 1999
    Date of Event
    June 11, 1999
    Report Date
    June 14, 1999
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROFOUND HYPOTENSION AFTER 50 MLS OF BEDSIDE-FILTERED, POOLED (6) PLATELETS. BP RETURNED TO BASELINE AFTER PLATELETS STOPPED. PT PREOP FOR LARYNGEAL CANCER. THIS WAS PT'S FIRST BLOOD TRANSFUSION. PT WAS ON ACE INHIBITOR (MONOPRIL) AND FILTER WAS PALL PURECELL PL (PL6T). NO EVIDENCE OF HEMOLYSIS, BACTERIAL CONTAMINATION OR IGA DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BEDSIDE LEUKOCYTE-REDUCTION FILTER CAK PALL BIOMEDICAL PRODUCTS CO. PURECELL PL (PL6T) *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention