PALL "ULTIPOR" 100 BREATHING SYSTEM

Additional Manufacturer Narrative

TWO (2) BB100AF BREATHING FILTERS (ONE UNUSED FILTER FROM LOT 704902 AND ONE USED FILTER WITH LOT NUMBER PROVIDED BY THE HOSPITAL AS 719802) WERE RETURNED TO OUR SCIENTIFIC LABORATORY SERVICES FACILITY FOR EVALUATION. USING OUR STANDARD LABORATORY TESTING PROTOCOL, THE INSPIRATORY AIRFLOW DELTA P VALUE OBTAINED FROM THE RETURNED IMPLICATED BB100AF BREATHING FILTER WAS SIGNIFICANTLY HIGHER WHEN COMPARED TO THE VALUE MEASURED FOR THE RETURNED UNUSED BB100AF FILTER AND A CONTROL FILTER (MODEL BB100EFS) WHICH UTILIZES THE SAME FILTER MEDIA. THIS CONFIRMS THE CUSTOMER REPORT OF INCREASED INSPIRATORY RESISTANCE IN THE RETURNED IMPLICATED USED FILTER. THE RETURNED IMPLICATED FILTER, THE RETURNED UNUSED BB100AF FILTER AND THE CONTROL BB100EFS FILTER PASSED THE HYDROPHOBICITY TEST VERIFYING THAT THE FILTER MEDIA WAS CAPABLE OF BLOCKING THE DIRECT TRANSFER OF LIQUIDS. SURFACE TENSION TESTING OF THE FLUID USED FOR THE HYDROPHOBICITY TESTING SHOWED THAT THE FLUID HAD A LOWER SURFACE TENSION VALUE THAN THAT TAKEN FROM THE PATIENT SIDE OF THE RETURNED UNUSED BB100AF FILTER AND THE CONTROL BB100EFS FILTER. THIS CONFIRMS THAT A SUBSTANCE ON THE SURFACE OF THE MEDIA WAS NOT DEPOSITED DURING THE MANUFACTURING PROCESS AND MOST LIKELY RESULTED FROM THE NEBULIZATION TREATMENT OF THE PATIENT AS STATED BY THE CUSTOMER. MANUFACTURING DATA TAKEN FROM THE PRODUCTION LOTS OF THE FILTER MEDIA, BEFORE DURING AND AFTER THE IMPLICATED LOT SHOWED NO ABNORMALITIES. MAINTENANCE RECORDS OF THE MANUFACTURING EQUIPMENT USED DURING THE PRODUCTION PERIODS SHOWED NO IRREGULARITIES. A BATCH AND NON-CONFORMANCE REVIEW WAS CONDUCTED FOR IMPLICATED LOT NUMBER 719802 AND NO ANOMALIES WERE IDENTIFIED. ALL QUALITY CONTROL AND RELEASE CRITERIA WERE ALSO REVIEWED AND CONFIRMED TO BE WITHIN SPECIFICATION. FURTHERMORE, A REVIEW OF OUR COMPLAINT DATABASE HAS CONFIRMED THAT THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE FOR A BB100AF FILTER, LOT NUMBER 719802 (LOT QUANTITY (B)(4) UNITS). ADDITIONALLY, A TREND SEARCH WAS PERFORMED FOR THE BB100 PRODUCT FAMILY PRODUCED SINCE JANUARY 2015 (MANUFACTURED QUANTITY(B)(4) UNITS) AND NO MANUFACTURING DEVIATIONS WERE FOUND. IN CONCLUSION, BASED ON OUR MANUFACTURING INVESTIGATIONS AND FILTER TESTING IT WAS DETERMINED THAT THE IMPLICATED PRODUCT MET ESTABLISHED PRODUCT SPECIFICATIONS AND COULD THEREFORE NOT BE THE CAUSE FOR THE REPORTED EVENT. THE VARIATION IN FLOW DETECTED IN THE IMPLICATED FILTER IS LIKELY RELATED TO THE MEDICATION NEBULIZED AND/OR CUSTOMER USE OF THE FILTER. THIS CONCLUSION IS SUPPORTED BY THE DATA FROM THE SCIENTIFIC LABORATORY SERVICES TEST RESULTS WHICH INDICATED THE PRESENCE OF A SUBSTANCE DEPOSITED ON THE SURFACE OF THE MEDIA ON THE USED FILTER WHICH WAS NOT PRESENT ON THE UNUSED OR CONTROL FILTER. MULTIPLE ATTEMPTS TO OBTAIN CONFIRMATION THAT THE PRODUCT'S INSTRUCTIONS FOR USE AND PRECAUTIONS WERE ADHERED TO WERE MADE, HOWEVER, OTHER THAN CONFIRMING THE USE OF NEBULIZED ATROVENT, THE REPORTING HOSPITAL DID NOT PROVIDE THE REQUESTED INFORMATION TO PALL. PATIENTS, IN GENERAL, SUPPORTED BY MECHANICAL VENTILATION REQUIRE CLOSE CLINICAL MONITORING. IN ADDITION, THE DEVICE LABELLING'S PRECAUTION STATEMENT PROVIDES INFORMATION ON CONSIDERATIONS NEEDED IN CERTAIN THERAPY MODES. IN PARTICULAR, THE PRECAUTIONS STATE: "RARELY AN INCREASED AIRFLOW RESISTANCE OCCURS WITH LIQUID DRUG NEBULIZATION WHICH MANDATES VIGILANCE." 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, IF A DEVICE WERE TO MALFUNCTION, WOULD DETERIORATE TO THE REPORTED PNEUMOTHORAX. SUMMARY: THE USER REPORT COULD NEITHER BE CONFIRMED NOR COMPLETELY DISCOUNTED. IT IS POSSIBLE THAT AN INCREASE IN FLOW RESISTANCE MAY HAVE OCCURRED; LIKELY RELATED TO THE MEDICATION NEBULIZED AND/OR CUSTOMER USE OF THE FILTER. PROPER PATIENT MANAGEMENT IS NOT EXPECTED TO RESULT IN PNEUMOTHORAX IN SUCH AN EVENT WHEN THE INSTRUCTIONS FOR USE INCLUDING PRECAUTIONS ARE OBSERVED. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

Description of Event or Problem

A COMPLAINT WAS RECEIVED FOR THREE OCCURRENCES, INVOLVING THREE DIFFERENT PATIENTS ((B)(6) 2017) FOR RESISTANCE TO PROVIDE OXYGEN TO THE PATIENTS USING A ULTIPOR 100 FILTER, PART NUMBER BB100AF, LOT# 719802. IT WAS REPORTED THAT BI-LATERAL PNEUMOTHORAX WITH SUBCUTANEOUS EMPHYSEMA AND BRADYCARDIA WAS EXPERIENCED IN THE ICU WITH EACH PATIENT ON VENTILATION. IT WAS REPORTED THAT THE INVOLVED PATIENTS REQUIRED MEDICAL INTERVENTION AND SUBSEQUENTLY DIED. THIS MDR REPORT (9680602-2018-0001) IS BEING SUBMITTED FOR THE FIRST NOTED INCIDENT ON (B)(6) 2017. A SEPARATE MEDWATCH REPORT WILL BE SUBMITTED FOR EACH INCIDENT (MFG. REPORT # 9680602-2018-00001, 9680602-2018-00002 AND 9680602-2018-00003). THE CUSTOMER REPORTED THAT ONE PATIENT WAS DIAGNOSED WITH SEPSIS AND ONE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION (UTI). IT IS UNKNOWN WHICH PATIENT WAS INVOLVED IN WHICH OCCURRENCE. NO OTHER PATIENT INFORMATION, OR DETAILS OF THE OCCURRENCES WERE PROVIDED BY THE HOSPITAL. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL EVENT DETAILS. A PALL MEDICAL CLINICAL SPECIALIST VISITED THE HOSPITAL IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE OCCURRENCE AND PATIENT. UNFORTUNATELY, THE CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL DETAILS OTHER THAN THE PATIENT FROM (B)(6) 2017 HAD RECEIVED NEBULIZATION TREATMENT OF ATROVENT. THE DURATION OF USE OF THE IMPLICATED FILTERS COULD NOT BE ASCERTAINED. DURING THE SITE VISIT WHEN QUESTIONED HOW THIS OCCURRENCE WAS ATTRIBUTED TO THE USE OF THE BB100AF, THE HOSPITAL STATED STAFF RECALLED SIMILAR SYMPTOMS OCCURRING WITH TWO PATIENTS ON (B)(6) 2017 AND CONCLUDED THAT THE FILTER WAS A CONTRIBUTING FACTOR, HOWEVER THE CUSTOMER COMMUNICATED THAT THIS WAS SPECULATION ON THEIR PART. THE CUSTOMER REPORTED THAT ON (B)(6) 2017, A HOSPITAL NURSE AND THERAPIST PERFORMED A FUNCTIONAL COMPARISON USING AN UNUSED FILTER (LOT 704902) AND THE IMPLICATED USED FILTER FROM THE (B)(6) 2017 OCCURRENCE (COMMUNICATED LOT 719802). THE CUSTOMER REPORTED THAT NO INSPIRATORY RESISTANCE WAS PRESENT WITH THE UNUSED FILTER. NO INFORMATION WAS PROVIDED REGARDING THEIR TESTING OF THE USED FILTER. THE BB100AF FILTER ASSOCIATED WITH THIS INCIDENT ((B)(6) 2017) WAS NOT RETAINED BY THE USER. HOWEVER, ONLY THE BB100AF FILTER ASSOCIATED WITH THE (B)(6) 2017 INCIDENT (MFG. REPORT # 9680602-2018-00003) DESCRIBED IN THE CUSTOMER COMPLAINT WAS RETAINED AND HAS BEEN RECEIVED AT PALL'S SCIENTIFIC LABORATORY SERVICES FACILITY FOR INVESTIGATION ALONG WITH AN UNUSED BB100AF FILTER, LOT# 704902. THE RETURNED DEVICES WERE EVALUATED AND EACH MDR IS BEING SUBMITTED WITH THE COMPLETION OF THE RETURNED FILTER INVESTIGATION.