BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL ULTIPOR 100 BREATHING SYSTEM FILTER

    MDR report key: 1221683 · Received November 7, 2008

    Report

    Report Number
    9680602-2008-00009
    Event Type
    Injury
    Date Received
    November 7, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 22, 2008
    Manufacturer
    PALL NEWQUAY
    Product Code
    CAH
    PMA / PMN Number
    K791307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE PATIENT OR DEVICE PROBLEMS (INCLUDING ANY FAILURE ANALYSES) NOTED IN THIS REPORT ARE PART OF A TREND ANALYSIS, PLEASE PROVIDE A COMPLETE LIST OF ALL RELATED MDR ACCESS NUMBERS, AS WELL AS THE BASIS FOR THEIR INCLUSION IN THE TREND, E.G., COMMON CLINICAL PRESENTATION/OBSERVATION, COMMON COMPONENT, COMMON MANUFACTURING PROCESS, KNOWN FAILURE MODE., ETC. RESPONSE: A COMPLETE LIST OF ALL RELATED MDR ACCESS NUMBERS SINCE 1996 IS HEREIN PROVIDED. THE BASIS FOR INCLUSION IN THIS LIST IS: USER REPORTS OF CLINICAL MANIFESTATIONS THAT COULD BE POTENTIALLY RELATED TO SOME INCREASED LEVEL OF RESISTANCE TO GAS FLOW IN THE DEVICE. ALSO, REPORTS OF INCREASED GAS FLOW RESISTANCE IN THE DEVICE (WITHOUT ANY CLINICAL MANIFESTATIONS). GLOBAL REPORTS THAT IMPLICATED ANY MODEL OF FILTER AND/OR HEAT & MOISTURE EXCHANGER MARKETED FOR USE IN BREATHING CIRCUITS OF MECHANICALLY VENTILATED PATIENTS (E.G. IN ICU, RESPIRATORY CARE). 2647898-1996-00007, 2647898-1996-00008, 2432733-1997-00003, 2432733-1997-00010, 2432733-1997-00027, 2432733-1997-00031, 2432733-1997-00042, 9680602-1997-00002, 2432733-1997-00064, 2432733-1998-00010, 2432733-1998-00026, 9680602-1998-00006, 9680602-1998-00008, 2647898-1999-00008, 9680602-1999-00003, 9680602-1999-00004, 9680602-1999-00005, 9680602-1999-00006, 9680602-1999-00007, 9680602-1999-00008, 9680602-1999-00013, 2647898-2000-00009, 2647898-2000-00024, 2647898-2001-00004, 2647898-2001-00005, 2432733-2001-00001, 9680602-2001-00006, 9680602-2001-00015, 2647898-2001-00031, 9680602-2001-00026, 9680602-2001-00027, 2647898-2001-00036, 9680602-2001-00028, 9680602-2002-00001, 9680602-2004-00001, 9680602-2004-00003, 2647898-2004-00002, 2647898-2004-00003, 2647898-2004-00004, 2647898-2004-00005, 2647898-2004-00006, 2647898-2004-00007, 2647898-2004-00009, 2647898-2004-00010, 2647898-2004-00012 2647898-2004-00013, 2647898-2004-00015, 9680602-2004-00007, 9680602-2005-00013, 2647898-2006-00001, 9680602-2006-00002, 9680602-2006-00003, 9680602-2006-00007, 9680602-2007-00002, 9680602-2007-00011, 9680602-2007-00017, 9680602-2007-00018, 9680602-2008-00003, 9680602-2008-00004, 9680602-2008-00005. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED IN THE FIRM'S LABORATORIES. VISUAL INSPECTION OF THE DEVICE DISCLOSED AN APPEARANCE THAT WAS SIMILAR TO THAT OF AN UNUSED DEVICE TAKEN FROM INVENTORY TO SERVE AS A CONTROL, EXCEPT FOR FLUID DROPLETS OBSERVED ON THE INSIDE OF THE HOUSING OF THE PATIENT AND MACHINE SIDES. THE RETURNED DEVICE WAS THEN SUBJECTED TO A STANDARD FLOW RESISTANCE (DELTA P TEST), UNDER BOTH DRY AND WET CONDITIONS. THE UNUSED CONTROL DEVICE WAS TESTED IN PARALLEL. UNDER DRY CONDITIONS, DELTA P TESTING WAS PERFORMED. THE RESULTS OBTAINED ARE SHOWN IN THE TABLE BELOW. DELTA P RESULTS: RETURNED DEVICE (CM H2O) CONTROL DEVICE (CM H2O) AIRFLOW DELTA P DELTA P (L/MIN) 0 0.2 0.0 10 0.6 0.2 20 0.9 0.4 30 1.4 0.8 40 1.7 1.1 50 2.1 1.5 60 2.4 1.7 70 2.9 2.1 80 3.2 2.4 90 3.8 2.8 UNDER WET CONDITIONS (I.E., THE HYDROPHOBICITY TESTING, THE RESULTS OF WHICH WILL FOLLOW) THE FLOW RESISTANCE TEST RESULTS WERE AS FOLLOWS: AIRFLOW RETURNED DEVICE (CM H2O) CONTROL DEVICE (CM H2O) (L/MIN) DELTA P DELTA P 0 0.0 0.1 10 0.6 0.4 20 1.3 0.7 30 2.8 1.0 40 2.8 1.3 50 3.8 1.6 60 4.8 1.9 70 5.8 2.3 80 6.4 2.6 90 8.1 3.1 STANDARD HYDROPHOBICITY TESTING WAS PERFORMED ON BOTH THE RETURNED AND CONTROL DEVICES. THE UNUSED CONTROL FILTER PASSED THIS TEST, BUT THE USED, RETURNED FILTER FAILED THIS TEST, ALLOWING A SMALL AMOUNT OF LIQUID TO PASS THROUGH THE FILTER. SURFACE TENSION TESTING OF THE LIQUID REMAINING AFTER THE HYDROPHOBICITY TEST SHOWED A DECREASED SURFACE TENSION OF THE LIQUID IN THE PATIENT SIDE OF THE RETURNED FILTER; TESTING OF LIQUID ON THE MACHINE SIDE OF THE RETURNED FILTER WAS NOT POSSIBLE DUE TO THE SMALL VOLUME THAT PASSED. CONCLUSION THE USER REPORT OF HIGH LINE PRESSURE OCCURRING WITH THE DEVICE IN THE BREATHING CIRCUIT WAS CONFIRMED. THE DIFFERENTIAL PRESSURES ACROSS THE TEST FILTER AS RECEIVED ("DRY") AND AFTER THE STANDARD HYDROPHOBICITY TEST ("WET") WERE HIGHER THAN THE PRESSURES ACROSS THE CONTROL FILTER. THIS MAY HAVE BEEN DUE TO THE HYDROPHOBICITY OF THE MEDIA BEING COMPROMISED AND STARTING TO WET OUT, INCREASING THE RESISTANCE TO AIR FLOW. THIS SUPPOSITION IS CONSISTENT WITH THE RESULTS OF THE STANDARD HYDROPHOBICITY AND SURFACE TENSION TESTS. THE USER REPORTED THAT THE DRUGS ALBUTEROL AND IPRATROPIUM HAD BEEN NEBULIZED WITH THE FILTER IN SITU. NEBULIZED SUBSTANCES CAN HAVE DETERGENT PROPERTIES IF THEY CONTAIN SURFACTANTS, AND THESE PROPERTIES CAN ALTER THE HYDROPHOBIC NATURE OF THE FILTER MEDIA AND CAUSE AN INCREASED RESISTANCE TO AIRFLOW. THIS PHENOMENON IS ADDRESSED BY THE DEVICE LABELLING, WHICH STATES: "PRECAUTIONS: RARELY, AN INCREASE IN AIRFLOW RESISTANCE OCCURS IN THE PRESENCE OF LIQUID DRUG NEBULIZATION, WHICH MANDATES VIGILANCE." IN THIS EVENT, AND IN MOST PREVIOUS INSTANCES WHEN PATIENT MONITORING DETECTS, IN A TIMELY MANNER, INCREASES IN AIRFLOW RESISTANCE THAT ARE ATTRIBUTED TO THE DEVICE, THE DEVICE IS REMOVED OR REPLACED WITHOUT SERIOUS PATIENT SEQUELAE RESULTING. SUMMARY: THE REPORTED EVENT WAS CONFIRMED. THE EVENT MAY HAVE BEEN CAUSED BY THE NATURE OF THE DRUGS EMPLOYED IN CONJUNCTION WITH THE DEVICE. A PRECAUTION IS PRESENT IN THE DEVICE LABELLING ADDRESSING THIS TYPE OF EVENT. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVING MECHANICAL VENTILATION USING THE DEVICE DEVELOPED RESPIRATORY DISTRESS, AND BECAME CYANOTIC AND UNRESPONSIVE, ALTHOUGH PULSE WAS REGULAR AND PALPABLE. THE ATTENDING STAFF REMOVED THE PATIENT FROM THE MECHANICAL VENTILATOR AND BEGAN MANUAL VENTILATION AND THE PATIENT WAS RESUSCITATED SUCCESSFULLY. THE CIRCUIT WAS EXAMINED AND THE DEVICE WAS DETERMINED TO BE BLOCK. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE AND MECHANICAL VENTILATION WAS RESUMED. NO SEQUELAE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL ULTIPOR 100 BREATHING SYSTEM FILTER BREATHING CIRCUIT FILTER CAH PALL NEWQUAY BB100AF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention