BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL BDS OXYGEN ANALYZER

    MDR report key: 5137391 · Received September 7, 2004

    Report

    Report Number
    5137391
    Event Type
    Injury
    Date Received
    September 7, 2004
    Date of Event
    August 27, 2004
    Report Date
    September 3, 2004
    Manufacturer
    PBI - DANSENSOR A/S,
    Product Code
    CCL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PALL MEDICAL CORPORATION'S DEVICE THE PALL BDS OXYGEN ANALYZER TESTED AN PLATELETS, APHERESIS UNIT AS A FALSE NEGATIVE FOR BACTERIA. THE UNIT WAS TESTED AND THEN SPLIT INTO TWO PRODUCTS. THE TWO PRODUCTS WERE DISTRIBUTED AND TRANSFUSED TO TWO DIFFERENT PATIENTS. BOTH PATENTS HAD AN INCREASE IN TEMPERATURE AND PULSE. THEY ALSO EXPERIENCED CHILLS. THE UNITS WERE SUSPECTED TO BE CONTAMINATED WITH BACTERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BDS OXYGEN ANALYZER OXYGEN ANALYZER CCL PBI - DANSENSOR A/S, NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention