PALL ULTIPOR 25 BREATHING SYSTEM FILTER

Additional Manufacturer Narrative

THE RETURNED USED BB25F FILTER (FROM LOT NUMBER 714802) WAS INVESTIGATED BY PALL SCIENTIFIC AND LABORATORY SERVICES. A VISUAL EXAMINATION OF THE USED FILTER REVEALED A CRACK IN ONE OF THE ENDCAPS ON THE FILTER HOUSING. THE RETURNED FILTER WAS THEN SUBJECTED TO AIRFLOW (DELTA) P (PRESSURE DIFFERENTIAL), AIR LEAKAGE AND HYDROPHOBICITY TESTING. AIRFLOW (DELTA) P VALUES FOR THE RETURNED BB25F FILTER WERE REDUCED COMPARED TO A CONTROL FILTER AT 60 L/MIN (3.6 CMH2O FOR THE CONTROL FILTER AND 3.1 CMH2O FOR THE RETURNED FILTER, IN BOTH DIRECTIONS). AIR LEAKAGE TESTING FROM THE RETURNED USED BB25F FILTER WAS GREATER THAN 25 ML/MIN AND LEAKAGE FROM THE CONTROL FILTER WAS LESS THAN 1 ML/MIN. THE RETURNED USED BB25F FILTER FAILED HYDROPHOBICITY TESTING DUE TO LEAKAGE THROUGH THE CRACK IN ONE OF THE ENDCAPS, IMMEDIATELY WATER WAS INTRODUCED INTO THE FILTER HOUSING. WE CAN THEREFORE CONFIRM THE CUSTOMER'S OBSERVATION THAT THE RETURNED USED FILTER WAS LEAKING DUE TO A CRACK IN ONE OF THE ENDCAPS OF THE FILTER HOUSING. AN ASSEMBLY BATCH DOCUMENTATION AND NON-CONFORMANCE REVIEW WAS CONDUCTED AND NO ISSUES WERE IDENTIFIED THAT COULD BE LINKED TO THIS REPORTED DEVIATION. A REVIEW OF OUR COMPLAINT DATABASE HAS CONFIRMED THAT THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE FOR A BB25F FILTER WITH LOT NUMBER 714802. VISUAL EXAMINATION OF THE BB25F FILTER WAS THEN CONDUCTED BY OUR MANUFACTURING FACILITY. IT WAS DETERMINED THAT THE MARKINGS ON THE FILTER WERE CONSISTENT TO MARKS SEEN ON FILTERS WHEN THEY ARE CAUGHT IN THE JAWS OF THE ILAPAK PACKING MACHINE. A TRIAL WAS CONDUCTED TO REPLICATE THE ISSUE OF A FILTER JAMMING IN THE ILAPAK JAWS AND THE FILTERS COMPARED, THIS SHOWED THAT THE MARKS AND THE INDENTATIONS WERE THE SAME. THE TRIAL ALSO CONCLUDED THAT THE ILAPAK MACHINE WAS WORKING CORRECTLY AND ALARMING OUT WHEN A FILTER WAS CAUGHT. THE PROCEDURE FOR ILAPAK PACKING 6665 WAS THEN REVIEWED AND IT STATES THAT IF ANY PRODUCT IS CAUGHT IN THE JAWS THEN THE PRODUCT IS TO BE REJECTED. HOWEVER IT DOES NOT DETAIL THAT ANY ALARMS OR THE AMOUNT OF REJECTS SHOULD BE RECORDED, THUS IT IS UNKNOWN IF THE FILTER WAS CAUGHT IN THE JAWS, THE MACHINE ALARMED OUT AND THEN THE FILTER WAS REPACKED OR THE FILTER WAS CAUGHT IN THE JAWS AND THEN PROCEEDED THROUGH TO THE PACKING AREA. IN CONCLUSION THE ROOT CAUSE IS DEEMED TO BE THAT THE FILTER HAS BEEN CAUGHT IN THE ILAPAK JAWS CAUSING THE CRACK IN THE ENDCAP AND NOT BEEN DISCARDED. A REMEDIAL ACTION HAS BEEN MADE TO THE ILAPAK PACKING PROCEDURE 6665 TO DETAIL THAT ALL ALARMS ARE RECORDED ALONG WITH THE AMOUNT OF FILTERS REJECTED AT THE TIME. PROCEDURE 6665 HAS BEEN AMENDED AND WAS APPROVED ON THE DECEMBER 01, 2017. TRAINING OF ALL OPERATORS WAS COMPLETED ON DECEMBER 18, 2017. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

Additional Manufacturer Narrative

THE IMPLICATED FILTER HAS BEEN RETURNED TO PALL FOR INVESTIGATION. THE RETURNED DEVICE WILL BE EVALUATED AND FINDINGS WILL BE PUBLISHED, TARGET FOR COMPLETION (B)(4) 2018.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WAS UNDER ANESTHESIA WITH A PALL ULTIPOR 25 BREATHING SYSTEM FILTER AND THE USER MONITORED A LEAK ON THE PATIENT BREATHING CIRCUIT. THE CUSTOMER CHECKED THE BREATHING CIRCUIT AND OBSERVED A CRACK IN THE FILTER, SO THEY HAD TO CHANGE IT. NO ADVERSE EFFECTS ON THE PATIENTS WERE REPORTED. THE USER STATED, IN THEIR OPINION, THE LEAK PUT THE PATIENT AT RISK DUE TO INADEQUATE VENTILATION AND ANTI-BACTERIAL FUNCTION OF THE FILTER MIGHT HAVE BEEN AFFECTED. IMPLICATED REORDER CODE (B)(4) IS NOT REGISTERED AND SOLD IN THE US. ALL FDA INFORMATION BELOW IS RELATED TO "LIKE" PRODUCTS, UNDER 510K K791307, WHICH ARE REGISTERED FOR SALE IN THE US.