BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING CIRCUIT FILTER

    MDR report key: 276118 · Received May 3, 2000

    Report

    Report Number
    9680602-2000-00003
    Event Type
    Other
    Date Received
    May 3, 2000
    Date of Event
    March 5, 2000
    Report Date
    April 3, 2000
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    CAH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE REQUEST OF THE LUNG PHYSICIAN, THE PT WAS INTUBATED IN INTENSIVE CARE DUE TO SEVERE RESPIRATORY INSUFFICIENCY, BASED ON PNEUMONIA WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE PT WAS INTUBATED IN THE USUAL WAY AND TECHNIQUE, WITHOUT ANY PROBLEMS OR COMPLICATIONS. LATER ON INTRAVENOUS DORMICUM WAS GIVEN AS SEDATION. INITIALLY VENTILATION PARAMETERS WERE SET ON PRVC 14 X 800 ML INSPIRATION TIME 20% FIO2: 0.40 PEEP 0 (MEASURED INTRINSIC PEEP 8). THE ACTUAL MINUTE VOLUME (AMV) MEASURED WAS INITIALLY 11.1 L/MIN WITH A PPEAK OF 38 CM H20. THERE WERE ALOT OF SECRETIONS DURING SUCTIONING. AFTER ABOUT 15 MINUTES PROBLEMS OCCURRED REGARDING INCREASING VENTILATOR PRESSURES AND DECREASING AMV (PPEAK TO APPROX.50 CM H20, AMV 4.9 L/MIN). IT WAS CLEAR THAT THE PT WAS BRONCHOSPASMIC. AFTER DISCONNECTION FROM THE VENTILATOR THERE WAS A VERY SLOW AND LONG EXPIRATORY FLOW FROM THE PT. AFTER RECONNECTION OF THE VENTILATOR INITIALLY SEEMED THAT NORMAL AMV WAS GOING TO BE ACHIEVED, BUT AFTER A FEW EXPIRATORY BREATHS THE PROBLEM REOCCURRED. THE CAPNOGRAPH CLEARLY HAD A BRONCHOSPASMIC SET. THE BLOOD GAS ANALYSIS SHOWED SEVERE RESPIRATORY ACIDOSIS (PH 7.7, PACO2 107.2). THE MEDICATION DOSES WERE INCREASED (VENTOLIN/ATROVENT BY NEBULIZATION, DAF INTRAVENOUSLY, ENPHYLINNE INTRAVENOUSLY, ADRENALINE BY NEBULIZATION AND AFTERWARDS VENTOLIN INTRAVENOUSLY). DESPITE THIS VERY EXTENSIVE THERAPY THE SITUATION ONLY SLIGHTLY IMPROVED. THE BLOOD GAS ANALYSIS STILL SHOWED SEVERE RESPIRATORY ACIDOSIS. THIS THEN LED TO THE PT BEING TREATED WITH HALOTHANE GAS, WHICH RESULTED IN AN AMV OF 12.3 L/MIN WITH PPEAK OF 39 CM H2O). AFTER APPROXIMATELY, 4 HOURS AIR TRAPPING OCCURRED AGAIN. THE PT WAS RECONNECTED TO THE VENTILATOR ACCIDENTALLY WITHOUT THE DEVICE IN PLACE AND SUDDENLY THE PT'S RESPIRATORY PRESSURE DROPPED SEVERELY (PPEAK 29 MM HG). THE IMPLICATED DEVICE WAS REPLACED WITH A NEW DEVICE, AFTER WHICH VENTILATION IMPROVED AND THE RESPIRATORY ACIDOSIS NORMALIZED. NO PERMANENT ADVERSE EFFECTS ON THE PT RELATED TO THIS OCCURRENCE WERE REPORTED. DEVICE EVALUATION/ANALYSIS TO FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BREATHING CIRCUIT FILTER BREATHING CIRCUIT FILTER CAH PALL NEWQUAY, LTD. BB100 928102

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention