BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL ULTIPOR 25 BREATHING SYSTEM FILTER

    MDR report key: 7686638 · Received July 13, 2018

    Report

    Report Number
    9680602-2018-00004
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    June 19, 2018
    Report Date
    June 22, 2018
    Manufacturer
    PALL NEWQUAY
    Product Code
    CAH
    UDI-DI
    00636207000231
    PMA / PMN Number
    K791307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS UNDERWAY. WE ARE WAITING FOR THE HOSPITAL TO CONFIRM THAT THEY WILL BE RETURNING THE IMPLICATED FILTER TO PALL FOR TESTING. UPON RECEIPT THE RETURNED DEVICE WILL BE EVALUATED AND FINDINGS WILL BE PUBLISHED, TARGET FOR COMPLETION JULY 30TH, 2018.

    Additional Manufacturer Narrative · 1

    THE USED BB25G FILTER WAS RETURNED TO PALL SCIENTIFIC AND LABORATORY SERVICES AND OUR MANUFACTURING FACILITY FOR INVESTIGATION. THE RETURNED FILTER WAS SUBJECTED TO AIRFLOW, HYDROPHOBICITY AND SURFACE TENSION TESTING. AN UNUSED PALL ULTIPOR 25 BREATHING SYSTEM FILTER (BB25DF) WAS ALSO TESTED AS A CONTROL SAMPLE. THE RETURNED USED BB25G FILTER WAS VISUALLY EXAMINED AND OBSERVED TO BE IN ACCORDANCE WITH CURRENT MANUFACTURED PRODUCT. NO FLUIDS OR SECRETIONS WERE OBSERVED ON THE PATIENT OR MACHINE SIDE OF THE FILTER. THE AIRFLOW DELTA (P) VALUE OBTAINED FOR THE RETURNED USED BB25G BREATHING FILTER WAS INCREASED PRE HYDROPHOBICITY TESTING COMPARED TO THE CONTROL BB25DF FILTER AT 60 L/MINUTE. AN AIRFLOW DELTA (P) VALUE COULD NOT BE OBTAINED FOR THE RETURNED USED BB25G BREATHING FILTER POST HYDROPHOBICITY TESTING AS THE PRESSURE WAS HIGHER THAN THE MAXIMUM VALUE ACHIEVABLE ON THE MANOMETER. THE RETURNED USED BB25G FILTER FAILED HYDROPHOBICITY TESTING WITH A HYDROSTATIC HEAD OF 15 CM AFTER 55 SECONDS (WATER THAT PASSED THROUGH THE FILTER MEDIA BECAME DISCOLOURED) AND THE CONTROL BB25DF FILTER PASSED THE HYDROPHOBICITY TESTING WITH A HYDROSTATIC HEAD OF 15 CM FOR 60 SECONDS. SURFACE TENSION TESTING SHOWED THAT THE FLUID THAT WENT THROUGH THE RETURNED USED BB25G BREATHING FILTER FROM THE PATIENT SIDE HAD LOWER SURFACE TENSION VALUES THAN THAT TAKEN FROM THE PATIENT SIDE OF THE CONTROL BB25DF FILTER. WE CAN THEREFORE CONFIRM THE HOSPITAL'S OBSERVATION THAT THE RETURNED USED BB25G FILTER HAD FLOW DIFFICULTIES. FAILED HYDROPHOBICITY TESTING DEMONSTRATES THAT THE FILTER MEDIA HAS BEEN COMPROMISED, MOST LIKELY DUE TO BEING EXPOSED TO A SUBSTANCE DURING USE WHICH HAS ALTERED THE HYDROPHOBIC PROPERTIES OF THE FILTER AND RESULTED IN THE REPORTED FLOW DIFFICULTY. THE HOSPITAL REPORTED THAT THE TUBING USED IN THE BREATHING CIRCUIT IS REPROCESSED (WASHING, DISINFECTION, AIR-DRYING). IF ANY DISINFECTION RESIDUES HAVE COME IN TO CONTACT WITH THE FILTER MEDIA THEN THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE FOR THE PALL ULTIPOR 25 BREATHING SYSTEM FILTERS CONTAIN THE STATEMENT "DO NOT SOAK, RINSE, WASH, STERILISE OR TREAT WITH LIQUID DISINFECTANTS." A BATCH PAPERWORK AND NON-CONFORMANCE REVIEW WAS CONDUCTED AND NO ANOMALIES WERE OBSERVED DURING THIS DOCUMENTATION REVIEW. THE LOT NUMBER FOR THE ONE IMPLICATED FILTER IS NOT KNOWN, BUT THE HOSPITAL BELIEVES IT TO BE FROM EITHER LOT NUMBER 731202, 805202 OR 810402. ALL THREE OF THESE POTENTIAL LOT NUMBERS WERE INCLUDED IN THE REVIEW OF THE MANUFACTURING RECORDS. ALL THE MACHINE SPECIFICATIONS WERE CHECKED AND CONFIRMED TO BE CORRECT. ALL PROCEDURES WERE FOLLOWED CORRECTLY. ALL QUALITY CONTROL AND RELEASE CRITERIA WERE REVIEWED AND CONFIRMED TO BE WITHIN SPECIFICATION. FURTHERMORE, A REVIEW OF OUR COMPLIANT DATABASE HAS CONFIRMED THAT THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE FOR A BB25G FILTER WITH LOT NUMBER 731202, 805202 OR 810402. FOR THE REASONS OUTLINED ABOVE, WE DO NOT BELIEVE THAT THE RETURNED USED BB25G FILTER WAS A CAUSAL OR CONTRIBUTORY FACTOR IN THIS INCIDENT. ADDITIONALLY, THE LAST NAME OF THE INITIAL REPORTER HAS BEEN REVISED TO SCHLOTT, IN THE INITIAL MDR SUBMISSION IT WAS INADVERTENTLY MISSPELLED AS SCHLO. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PALL ULTIPOR 25 BREATHING SYSTEM FILTER WAS IN USE AND AFTER 20 MINUTES IN THEATRE UNDER STANDARD LOW FLOW CONDITIONS, IT WAS NOTICED THAT THE REQUIRED FLOW RATE COULD NOT BE DELIVERED TO THE PATIENT. AFTER SWITCHING FROM LARYNGEAL MASK AIRWAY TO ENDOTRACHEAL INTUBATION, RE-ADJUSTMENT OF VENTILATOR SETTINGS, THE PATIENT REANIMATION WAS STARTED, WHICH WAS POSSIBLE AFTER THE FILTER WAS REMOVED. THE HOSPITAL HAS REPORTED TO PALL THAT THE PATIENT IS IN ICU, AT THIS STAGE THE PROGNOSIS IS UNKNOWN. THE PATIENT IS UNDER MECHANICAL VENTILATION AND NOT RESPONSIVE. THE LOT NUMBER OF THE ONE IMPLICATED FILTER IS NOT KNOWN, BUT THE HOSPITAL BELIEVES THAT THE FILTER COULD BE FROM ONE OF THE LAST THREE DELIVERIES THAT THEY RECEIVED. THOSE DELIVERIES WERE FILTERS FROM LOT NUMBERS 731202 (DATE OF MANUFACTURE 07 NOVEMBER 2017), 805202 (DATE OF MANUFACTURE 21 FEBRUARY 2018) AND 810402 (DATE OF MANUFACTURE 16 APRIL 2018). THE HOSPITAL DID ALSO INFORM PALL THAT THE TUBING USED IN THE BREATHING CIRCUIT IS REPROCESSED (WASHING, DISINFECTION, AIR-DRYING). THE HOSPITAL HAVE RETAINED THE FILTER. THEY ARE WAITING FOR AGREEMENT FROM BFARM BEFORE RETURNING THE FILTER TO PALL FOR INVESTIGATION. NOTE: IMPLICATED REORDER CODE BB25G 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527017 PALL ULTIPOR 25 BREATHING SYSTEM FILTER BREATHING FILTER CAH PALL NEWQUAY BB25G 00636207000231

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention