BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL MEDICAL

    MDR report key: 441540 · Received February 5, 2003

    Report

    Report Number
    441540
    Event Type
    Death
    Date Received
    February 5, 2003
    Date of Event
    January 14, 2003
    Report Date
    January 27, 2003
    Manufacturer
    PALL MEDICAL
    Product Code
    CAH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT TRANSFERRED TO THE FACILITY FROM ANOTHER FACILITY IN 2003 IN ACUTE RESPIRATORY FAILURE AND VENTILATOR-DEPENDENT. SUFFERED CARDIAC ARREST 9 DAYS LATER, POSSIBLY FROM BILATERAL PNEUMOTHORAX. BILATERAL CHEST TUBES PLACED; PATIENT RESUSCITATED AND PLACED BACK ON SERVO 300A VENTILATOR. ARREST OCCURRED AT 2345; PLACED BACK ON VENTILATOR AT 0030 THE NEXT DAY. VENTILATOR WOULD NOT VENTILATE, SO PATIENT WAS BAGGED MANUALLY WHILE BP7200 VOL. VENTILATOR WAS SET UP; PATIENT REMAINED STABLE. SERVO 300A VENTILATOR WAS TAKEN BACK TO CARDIOPULMONARY DEPARTMENT FOR INVESTIGATION; FOUND NOT TO VENTILATE TEST LUNG, BUT TO HIGH PRESSURE ALARM. IN LINE HME (PALL BB100A) WAS REMOVED; VENTILATOR THEN WORKED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL MEDICAL BB100A EXCHANGE FILTER CAH PALL MEDICAL BB100A 207307-207702

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death 1. SERVO 300A VENTILATOR,| 3. ALLEGIANCE ADAPTORS & NEBULIZER.| 2. ALLEGIANCE CIRCUIT TUBING (DISPOSABLE),