BEUDAMED
    FDA Adverse Event Other Summary report: N

    FALL BREATHING CIRCUIT FILTER WITH FLEX TUBE

    MDR report key: 315241 · Received February 7, 2001

    Report

    Report Number
    2647898-2000-00024
    Event Type
    Other
    Date Received
    February 7, 2001
    Date of Event
    December 31, 2000
    Report Date
    January 5, 2001
    Manufacturer
    PALL BIOMEDICAL INC.
    Product Code
    CAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH PRESSURE ALARM SOUNDED ON THE PT'S VENTILATOR. THE RESPIRATORY THERAPIST ENTERED THE ROOM AND FOUND SAW THE PT WAS PURPLE, AND CALLED THE NURSE. THE PT WAS REMOVED FROM THE VENTILATOR, SUCTIONED, AND MANUALLY RESPIRATED WITH 100% OXYGEN. THE PT CODED. THE PT'S RHYTHM WAS RESTORED WITH MASSAGE. AT THE TIME THE PT WAS REMOVED FROM THE VENTILATOR, TIDAL VOLUME WAS 250ML VS. 750ML PROGRAMMED. THE CIRCUIT WAS SUBJECTED TO A TROUBLE-SHOOTING PROCEDURE, AND IT WAS FOUND THAT THE FULL TIDAL VOLUME COULD BE DELIVERED WHEN THE DEVICE HAD BEEN REMOVED FROM THE CIRCUIT. AT A LATER TIME, THE REPORTER PLACED THE INVOLVED DEVICE IN ANOTHER CIRCUIT SET TO DELIVER A 750ML TIDAL VOLUME, AND AGAIN WAS ABLE TO OBTAIN ONLY 250ML AND SOUNDED A HIGH PRESSURE ALARM. IT WAS NOTED THAT MOISTURE WAS PRESENT IN THE DEVICE ON BOTH SIDES OF THE MEDIA. THE PT WAS ORIGINALLY ADMITTED TO THE ICU AFTER BEING FOUND AT HOME UNCONSCIOUS FOR UP TO TWO DAYS. THE PT APPEARS TO HAVE NO SEQUELAE FROM THIS EVENT AND IS STILL IN THE ICU. THE HEALTH CARE POLICY DID NOT ALLOW DISCLOSURE OF A PT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4564 FALL BREATHING CIRCUIT FILTER WITH FLEX TUBE BREATHING CIRCUIT FILTER CAH PALL BIOMEDICAL INC. BB100F 911007

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention