BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL ULTIPOR 100 BREATHING SYSTEM FILTER

    MDR report key: 1032750 · Received April 24, 2008

    Report

    Report Number
    9680602-2008-00002
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 27, 2008
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    CAH
    PMA / PMN Number
    K791307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS FIRST EVALUATED BY THE MANUFACTURING ENGINEERING DEPARTMENT AT ITS MANUFACTURING SITE. TESTING WAS PERFORMED AS PER STANDARD PROCEDURES. THE DEVICE WAS ETO DISINFECTED PRIOR TO TESTING. THE DEVICE PASSED STANDARD TESTS FOR PRODUCT RELEASE: LEAK, MEDIA INTEGRITY & DRY FLOW RESISTANCE (DELTA P) TEST. THE FLOW RESISTANCE REQUIREMENT FOR THIS DEVICE IS <2.1 CM. H2O; THE DEVICE TESTED AT 1.5 CM H2O.THE DEVICE WAS ASSEMBLED CORRECTLY AND COMPLIED WITH REQUIREMENTS FOR FUNCTIONALITY.THE DEVICE THEN WAS EVALUATED IN THE FIRM'S PRODUCT TEST LABORATORIES. EXTERNAL OBSERVATION OF THE DEVICE SHOWED THAT IT WAS REPRESENTATIVE OF THE CURRENT MANUFACTURED PRODUCT. FINE BLACK PARTICLES WERE OBSERVED IN THE MACHINE SIDE PORT. FLOW RESISTANCE (DELTA P) TESTING WAS DONE PRIOR TO AND AFTER A STANDARD HYDROPHOBICITY TEST. SURFACE TENSION ANALYSIS WAS ALSO PERFORMED. THE DELTA P READINGS TAKEN PRIOR TO THE STANDARD HYDROPHOBICITY TEST WERE SLIGHTLY HIGHER COMPARED TO THAT OF THE CONTROL DEVICE (2.2 CM H2O AT 60 LPM AIRFLOW. VS. 1.5 CM H2O AT 60 LPM AIRFLOW FOR A CONTROL DEVICE. THE RETURNED DEVICE PASSED THE STANDARD HYDROPHOBICITY TEST. THE WET DELTA P READINGS OF THE RETURNED DEVICES WERE NOTICEABLY HIGHER THAN THAT OF THE WET DELTA P READINGS OF THE CONTROL DEVICE. (13.4 CM H2O AT 60 LPM AIRFLOW VS. 1.6 CM H2O AT 60 LPM AIRFLOW. FOLLOWING THESE TESTS, SURFACE TENSION ANALYSIS WAS CARRIED OUT ON THE FLUID COLLECTED FROM THE PATIENT SIDE OF THE RETURNED DEVICE. THE CONTROL FOR THE SURFACE TENSION ANALYSIS WAS BOTTLED STERILE WATER. DE-IONIZED WATER WAS USED TO SET THE RANGE. THE FLUID FROM THE PATIENT SIDE HAD A SURFACE TENSION BETWEEN 69-74 DYNES/CM. THE CONTROL AND THE DE-IONIZED SAMPLE WERE ALSO BETWEEN THESE RANGES. THIS DATA CONFIRMED THE USER'S OBSERVATION BECAUSE THE WET DELTA P RESULTS WERE HIGHER THAN THE CONTROL DEVICE. IT WAS NOT REPORTED WHETHER ANY DRUGS HAD BEEN NEBULIZED WITH THE DEVICE IN SITU. IN GENERAL, DEPOSITION OF SIGNIFICANT AMOUNTS OF NEBULIZED MEDICATION CAN ELEVATE FLOW RESISTANCE IN THE DEVICE. THIS PHENOMENON IS DESCRIBED IN THE DEVICE'S LABELING AS A "PRECAUTION": "RARELY, AN INCREASED FLOW RESISTANCE OCCURS WITH LIQUID DRUG NEBULIZATION WHICH MANDATES VIGILANCE." IN A RELATED FASHION, RESISTANCE CAN INCREASE IF LIQUID MEDICATION IS ALLOWED TO SPILL OVER FROM THE NEBULIZER INTO THE DEVICE. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT FLOW THOUGH THE DEVICE BECAME BLOCKED DURING USE. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1