BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING SYSTEM FILTER

    MDR report key: 309413 · Received December 20, 2000

    Report

    Report Number
    9680602-2000-00009
    Event Type
    Other
    Date Received
    December 20, 2000
    Date of Event
    September 1, 2000
    Report Date
    November 22, 2000
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    CAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS UNDERGOING SURGERY FOR POST-OPERATIVE BLEEDING FOLLOWING HYSTERECTOMY. ANAESTHESIA WAS INDUCED USING THE DEVICE. THE PT WAS PLACED IN THE 20 DEGREES HEAD-DOWN POSITION (TO FACILITATE SURGERY) AND PROGRESSIVELY HIGH INFLATION PRESSURES WERE REQUIRED TO VENTILATE THE PT. LUNG COMPLIANCE WAS FOUND TO BE MARKEDLY DECREASED. AIRWAY PRESSURES CONTINUED TO RISE IN EXCESS OF 60 CM H20, WITH TIDAL VOLUMES OF ONLY 20-30ML. PULMONARY CEDEMA FLUID WAS NOTED IN THE TRACHEAL TUBE AND DEVICE. THE TUBE WAS DISCONNECTED DISTAL TO THE DEVICE TO ALLOW SUCTION AND APPROXIMAELY 100 ML OF PULMONARY CEDEMA FLUID WAS EJECTED UNDER PRESSURE. THE TUBING WAS RECONNECTED AND MANUAL VENTILATION PROVED TO BE IMPOSSIBLE. THE DEVICE WAS CHANGED FOR A LARGER MODEL OF THE DEVICE. VENTILATION IMMEDIATELY BECAME EASIER AND COMPLIANCE AND AIRWAY PRESSURE RETURNED TO NORMAL. DURING THE COUSE OF THE REMAINING 45 MINUTES OF ANAESTHESIA, THE LARGER DEVICE WAS CHANGED A FURTHER THREE TIMES. ON EACH OCCASION AIRWAY PRESSURES DROPPED BY 10 CMH2O. NO PT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BREATHING SYSTEM FILTER SMALL VOLUME HEAT AND MOISTER EXCHANGER CAH PALL NEWQUAY, LTD. BB25FG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening| R