BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT

    MDR report key: 5577347 · Received April 14, 2016

    Report

    Report Number
    1417411-2016-00045
    Event Type
    Death
    Date Received
    April 14, 2016
    Date of Event
    March 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. IT WAS RECEIVED WITHOUT WATER IN THE BOTTLE. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE SAMPLE HAD TWO FAULT POINTS IN THE IN THE SILICONE LINING OF THE SNAP ADAPTOR. IT WAS ALSO FOUND THAT THERE WAS DAMAGE ON THE THREAD OF THE ADAPTOR. FUNCTIONAL TESTING WAS PERFORMED AND THE SAMPLE WAS ATTACHED TO A HUDSON RCI FLOW METER AND INSPECTED FOR OXYGEN FLOW AT BOTH 6 L/MIN AND 10 L/ MIN USING A TSI 4000 SERIES FLOWMETER. AIRFLOW WAS CONFIRMED WITH 5.98 L/MIN (WITH FLOW METER SET TO 6 L/MIN) AND 8.5-9 L/MIN (WITH FLOW METER SET TO 10 L/MIN), RESPECTIVELY. IN ADDITION, THE SAMPLE WAS TESTED FOR LEAKAGE USING SAWGELOK SNOOP LIQUID LEAK DETECTION SOAP AND IT WAS OBSERVED THAT BUBBLES WERE ESCAPING FROM THE BOTTLE ASSEMBLY. ADDITIONAL TESTING WAS PERFORMED AND THE ADAPTOR WAS ATTACHED TO AN UNOPENED 340ML AQUAPAK PRE-FILLED HUMIDIFIER BOTTLES. AIRFLOW WAS CONFIRMED WITH 6.62 L/MIN (WITH FLOW METER SET TO 6.5 L/MIN) AND 10.15 L/MIN (WITH FLOW METER SET TO 10 L/MIN), RESPECTIVELY. OTHER REMARKS: BASED ON THE INVESTIGATION PERFORMED THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE SAMPLE PASSED THE FUNCTIONAL TESTING AND THE COMPLAINT COULD NOT BE REPLICATED UNDER IFU/LABEL INSTRUCTIONS. THE SAMPLE PASSED BOTH WITH AND WITHOUT WATER IN THE BOTTLE. REGARDING THE DAMAGE ON THE THREAD OF THE ADAPTOR, A CAPA WAS OPENED TO ADDRESS THIS ISSUE. ALL MANUFACTURING PERSONNEL FROM THE MOLDING AREA RELATED TO THIS PROCESS WERE NOTIFIED OF THIS CUSTOMER COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: ADDITIONAL INFORMATION REGARDING THIS EVENT AND CAUSE OF PATIENT DEATH HAS BEEN REQUESTED. TO DATE, NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS REPORT. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORD REVIEW SHOWED THAT THERE WERE NO FUNCTIONAL ISSUES RELATED TO ON THE MOLDED COMPONENTS INVOLVED IN THIS COMPLAINT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED (THE OXYGEN DIDN'T PASS THROUGH THE AQUAPAK), TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY AND IT IS NOT BEING MANUFACTURED AT THE TIME. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO "OXYGEN DIDN'T PASS THROUGH THE AQUAPAK".

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT A MALE PATIENT WITH A TRACHEOCANULA GOT INTO DISTRESS (NOT IN THE ICU) AND IT WAS DECIDED BY THE NURSE AND DOCTOR TO DELIVER OXYGEN TO THE PATIENT TO COUNTER DESATURATION. AN AQUAPAK WAS ALREADY MOUNTED ON THE FLOW METER FOR THE DELIVERY OF OXYGEN VIA THE AQUAPAK, BUT THE PATIENT DIDN'T RECOVER. THE MEDICAL STAFF CHECKED ALL PARAMETERS (TRACHEOCANULA) AND NOTICED THAT THE OXYGEN DIDN'T PASS THROUGH THE AQUAPAK. A SECOND FLOW METER WAS ALSO TESTED AND OPENED THE OXYGEN AND ALREADY FELT OXYGEN BEFORE REACHING THE BOTTLE. THIS BOTTLE REMAINED UNOPENED. THE PATIENT GOT MORE AND MORE IN DISTRESS AND EVENTUALLY DIED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT A MALE PATIENT WITH A TRACHEOCANULA GOT INTO DISTRESS (NOT IN THE ICU) AND IT WAS DECIDED BY THE NURSE AND DOCTOR TO DELIVER OXYGEN TO THE PATIENT TO COUNTER DESATURATION. AN AQUAPAK WAS ALREADY MOUNTED ON THE FLOW METER FOR THE DELIVERY OF OXYGEN VIA THE AQUAPAK, BUT THE PATIENT DIDN'T RECOVER. THE MEDICAL STAFF CHECKED ALL PARAMETERS (TRACHEOCANULA) AND NOTICED THAT THE OXYGEN DIDN'T PASS THROUGH THE AQUAPAK. A SECOND FLOW METER WAS ALSO TESTED AND OPENED THE OXYGEN AND ALREADY FELT OXYGEN BEFORE REACHING THE BOTTLE. THIS BOTTLE REMAINED UNOPENED. THE PATIENT GOT MORE AND MORE IN DISTRESS AND EVENTUALLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233925 HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 492157

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death