BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL ULTIPOR 100 BREATHING SYSTEM FILTER

    MDR report key: 1932235 · Received December 17, 2010

    Report

    Report Number
    9680602-2010-00013
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 23, 2010
    Manufacturer
    PALL NEWQUAY
    Product Code
    CAH
    PMA / PMN Number
    K791307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO CONDUCT LABORATORY TESTING OF THE DEVICE LISTED IN THE USER MEDWATCH REPORT BECAUSE THE USER WAS UNWILLING TO PROVIDE THE DEVICE FOR LABORATORY EVALUATION. A FAILURE ANALYSIS WAS NOT POSSIBLE BECAUSE THE REPORTER DID NOT: KNOW THE MANUFACTURING LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT, FAILED TO PROVIDE ANY INFORMATION CONCERNING THE TIME COURSE OF THE USE OF THE DEVICE, STATE THE CONCOMITANT MEDICATIONS, DELINEATE THE VENTILATOR PARTICULARS, SETTINGS AND ALARMS DESPITE NUMEROUS ATTEMPTS BY THE MANUFACTURER TO OBTAIN SUCH INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE BECAUSE THE REPORTER DID NOT PROVIDE THE LOT NUMBER OR MODEL OF DEVICE THAT WAS IN USE. THE REPORTER PROVIDED NO INFORMATION IN THE MEDWATCH 3500A FIELDS AS FOLLOWS: NUMEROUS ATTEMPTS BY THE MANUFACTURER TO OBTAIN THE DEVICE INVOLVED AND THE INFORMATION LISTED ABOVE WERE NON-PRODUCTIVE. IN GENERAL PATIENTS WHO ARE SUPPORTED BY MECHANICAL VENTILATION REQUIRE CLOSE DIRECT CLINICAL MONITORING AS WELL AS MONITORING OF THE VENTILATOR AND ITS ACCESSORIES. VENTILATOR ALARMS SHOULD BE ADEQUATELY SET, AND RESPONDED TO PROMPTLY WHEN TRIGGERED. IN ADDITION, THE DEVICE LABELING'S PRECAUTION STATEMENT PROVIDES INFORMATION ON CONSIDERATIONS NEEDED IN CERTAIN THERAPY MODES. IN PARTICULAR, THE PRECAUTIONS STATE: "ALTHOUGH RARE, PROGRESSIVE INCREASE IN RESISTANCE TO AIRFLOW MAY OCCUR DURING LIQUID DRUG NEBULIZATION. THEREFORE, VIGILANCE SHOULD BE MAINTAINED." AND "VENTILATOR ALARMS SHOULD BE IN USE AT ALL TIMES." WHEN SUCH PRECAUTIONS ARE OBSERVED, IT IS NOT EXPECTED THAT THE MANAGEMENT OF A PATIENT IN THE CASE OF A DEVICE MALFUNCTION WOULD DETERIORATE TO THE POINT OF DEVELOPING A SUBCUTANEOUS AIR MASS, AND SIGNIFICANT BAROTRAUMA LEADING TO THE REPORTED PNEUMOTHORAX AND RESPIRATORY FAILURE. SUMMARY: THE USER REPORT COULD NEITHER BE CONFIRMED NOR DISCOUNTED. IT IS POSSIBLE THAT AN INCREASE IN FLOW RESISTANCE MAY HAVE OCCURRED; IF SO THE CAUSE IS INDETERMINATE. PROPER PATIENT MANAGEMENT IN SUCH A CASE IS NOT EXPECTED TO RESULT IN PNEUMOTHORAX OR RESPIRATORY FAILURE WHEN THE INSTRUCTIONS FOR USE INCLUDING THE PRECAUTIONS ARE OBSERVED, AND GOOD CLINICAL PRACTICE IS IN PLACE. FINALLY, REGARDING THE CHECK BOX TICKED FOR DISABILITY OR PERMANENT DAMAGE; THERE IS NO EVIDENCE PRESENTED OF THAT OUTCOME; THE REPORT WAS SUBMITTED ONLY 5 DAYS AFTER THE EVENT ITSELF. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    ON THE ANALYSIS PROVIDED UNDER FOLLOW UP REPORT #1: UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED OF AN ACUTE EPISODE OF CYANOSIS, CHANGE IN HEART RATE, RESPIRATORY ARREST. CODE BLUE CALLED, NO BREATH SOUNDS HEARD. NO AIR MOVEMENT, WEAK PULSE, NO VENTILATION ON VENT. SUBCUTANEOUS AIR MASSIVE, SCROTUM VERY EDEMATOUS. RT BEGAN WITH AMBU AT 100%, MET RESISTANCE. AMBU DIRECTLY TO TRACH (REMOVED FILTER) WITHOUT RESISTANCE. CXR SHOWED L PNEUMOTHORAX, CHEST TUBE INSERTED AND CONNECTED TO WALL SUCTION, PATIENT TRANSFERRED TO SCU. RT USED AMBU AT 100%, MET RESISTANCE, AFTER BRONCH, AMBU WITHOUT FILTER AND NORMAL VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL ULTIPOR 100 BREATHING SYSTEM FILTER BREATHING CIRCUIT FILTER CAH PALL NEWQUAY BB100A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention