BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING CIRCUIT FILTER WITH FLEX TUBE

    MDR report key: 322510 · Received March 23, 2001

    Report

    Report Number
    2647898-2001-00003
    Event Type
    Other
    Date Received
    March 23, 2001
    Date of Event
    February 3, 2001
    Report Date
    February 20, 2001
    Manufacturer
    PALL BIOMEDICAL INC.
    Product Code
    CAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH SEPSIS AND PULMONARY FAILURE, WAS BEING VENTILATED THROUGH THE DEVICE AND CODED. WHEN THE RESPIRATORY THERAPIST ARRIVED, THE PT WAS IN RESPIRATORY ARREST AND THEY IMMEDIATELY BEGAN CPR. THE RESPIRATORY THERAPIST NOTICED THAT THE DEVICE WAS CREATING RESISTANCE TO AIRFLOW. THE DEVICE WAS REMOVED AND THE VENTILATOR STARTED TO CYCLE CORRECTLY. THE RT PLACED THE DEVICE BACK IN THE UNIT AND THE VENTILATOR STOPPED CYCLING. THE DEVICE WAS AGAIN REMOVED AND THE PT WAS THEN RECONNECTED TO THE VENTILATOR (WITHOUT THE DEVICE) AND TRANSFERRED TO ICU. THE PT SUCCESSFULLY RECOVERED FROM THE CARDIAC ARREST. THE HEALTH CARE FACILITY DETERMINED THAT THE DEVICE WAS OCCLUDED AND FOUND THE SAME PROBLEM WITH PRODUCT FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12853 PALL BREATHING CIRCUIT FILTER WITH FLEX TUBE BREATHING CIRCUIT FILTER CAH PALL BIOMEDICAL INC. BB100F 032106

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R