BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL ULTIPOR 100 BREATHING SYSTEM FILTER

    MDR report key: 6501386 · Received April 18, 2017

    Report

    Report Number
    9680602-2017-00002
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    March 19, 2017
    Report Date
    March 21, 2017
    Manufacturer
    PALL NEWQUAY
    Product Code
    CAH
    PMA / PMN Number
    K791307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3 BB100P FILTERS THAT WERE PUT IN TO USE WERE NOT RETAINED BY THE HOSPITAL. THE 3 ADDITIONAL FILTERS THAT THE HOSPITAL LEAK TESTED, ALONG WITH A FURTHER (B)(4) UNUSED FILTERS FROM THE SAME LOT NUMBER, HAVE BEEN RETURNED TO OUR MANUFACTURING FACILITY FOR INVESTIGATION. THE RETURNED DEVICES WILL BE EVALUATED AND FINDING WILL BE PUBLISHED, TARGET FOR COMPLETION 5/31/2017. INVOLVED DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    IMPLICATED SAMPLES WERE NOT RETAINED HOWEVER THE CUSTOMER RETURNED 35 BB100P BREATHING FILTERS (32 UNUSED AND 3 TESTED BY THE CUSTOMER FROM LOT 603902). THE 35 FILTERS WERE TESTED AT PALL SLS FACILITY. THE 32 OF THE 35 FILTERS HAD A LEAK OBSERVED AROUND THE END CAP. THE FILTERS WERE THEN RETURNED TO OUR MANUFACTURING FACILITY AND THE LEAK WAS CONFIRMED. A TIMELINE OF THE IMPLICATED LOT SHOWED A SPIKE IN LEAK REJECTS DURING PRODUCTION WHICH RESULTED IN AN INVESTIGATION AND CORRECTION RELATING TO THE HEATER BANK AND THERMOCOUPLE. A SIGNIFICANT DECREASE IN LEAK REJECTS WAS OBSERVED AFTER THE CHANGE OF THE HEATER BANK AND THERMOCOUPLE. FILTERS PRODUCED PRIOR TO THE CHANGE WERE SAMPLED AND LEAK TESTED. ALL MET REQUIREMENTS. IN-PROCESS SAMPLING OF FILTERS PRODUCED AFTER THE CHANGE WERE LEAK TESTED AND MET REQUIREMENTS. ADDITIONALLY, THROUGHOUT THE MANUFACTURE OF LOT 603902 FILTERS WERE SAMPLED FOR BURST TESTING. ALL MET REQUIREMENTS. THE INVESTIGATION REVEALED THAT THE RETURNED LEAKING FILTERS WERE THE RESULT OF LOW PENETRATION OF THE ENDCAP WHEN ASSEMBLED WITH THE FILTER MEDIA HOUSING DURING THE PRODUCTION OF A SMALL PROPORTION OF FILTERS WITHIN LOT NUMBER 603902. THIS WAS DETERMINED TO BE CAUSED BY A HEATER BANK / THERMOCOUPLE ISSUE. THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN TAKEN: IT HAS BEEN DETERMINED THAT FILTERS WITHIN LOT NUMBER 603902 MAY NOT PERFORM IN ACCORDANCE WITH SPECIFICATIONS. IT HAS THEREFORE BEEN DECIDED BY PALL TO RECALL THE PALL ULTIPOR 100 BREATHING SYSTEM, CODE BB100P, LOT 603902 FROM THE MARKET. LOT 603902 WAS SHIPPED IN ITS ENTIRETY TO A FOREIGN COUNTRY. NO PRODUCT FROM LOT 603902 HAS BEEN SHIPPED TO THE UNITED STATES. REVISE LEAK TEST PROCEDURE TO IMPROVE GUIDANCE ON SPC YIELD MONITORING AND REJECT ALERT RESPONSE. COMPLETION DATE JUNE 5, 2017. IMPROVE INSPECTION PROCESS TO INCLUDE THE MONITORING FOR A POTENTIAL FILTER END CAP GAP. COMPLETION DATE MAY 30, 2017. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING A PALL ULTIPOR 100 BREATHING SYSTEM FILTER, PART NUMBER BB100P, FOR A PATIENT UNDER MACHINE VENTILATION, A KIND OF SPASM WAS OBSERVED IN THE PATIENT. THE FILTER WAS REPORTEDLY LEAKING. AFTER UNSUCCESSFUL APPLICATION OF MEDICATION, A MANUAL RESPIRATION USING RESPIRATORY BAGS BROUGHT SUCCESS, HEART FREQUENCY AND BLOOD PRESSURE NORMALIZED. THE IMPLICATED BB100P FILTER WAS REMOVED AND REPLACED AND THE PATIENT COULD BREATHE WITHOUT ANY PROBLEMS. NO PERMANENT ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THE HOSPITAL NOTED THAT AFTER THIS OCCURRENCE THEY CONDUCTED A LEAK TEST ON AN ADDITIONAL 3 UNUSED BB100P FILTERS FROM THE SAME LOT AS THE IMPLICATED FILTER AND OBSERVED LEAKAGE. THE HOSPITAL ALSO NOTED THAT THEY HAD A SIMILAR OCCURRENCE ON TWO PREVIOUS OCCASIONS WITH BB100P FILTERS FROM THE SAME LOT NUMBER, BUT THEY HAD NO DOCUMENTATION OR DETAILS CONCERNING THOSE TWO PREVIOUS OCCASIONS, OTHER THAN TO STATE THAT THERE WAS NO PATIENT INJURY. NOTE: IMPLICATED REORDER CODE BB100P IS NOT REGISTERED AND SOLD IN THE U.S. ALL FDA INFORMATION BELOW IS RELATED TO "LIKE" PRODUCTS, UNDER 510K# K791307, WHICH ARE REGISTERED FOR SALE IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282260 PALL ULTIPOR 100 BREATHING SYSTEM FILTER FILTER, BACTERIA, BREATHING SYSTEM CAH PALL NEWQUAY BB100P 603902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention