BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMIDIFIER EMPTY 3 PSI WHITE CAP 50/CS

    MDR report key: 3241387 · Received July 22, 2013

    Report

    Report Number
    8030673-2013-00046
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BTT
    PMA / PMN Number
    K991484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE FROM ACTUAL EVENT WAS DISCARDED. A REPRESENTATIVE SAMPLE FROM THE SAME LOT WAS SENT FOR EVALUATION TO THE MANUFACTURING PLANT. UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WOULD BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: THE CORRECT SAMPLE RECEIPT DATE WAS UPDATED TO 6-19-2013. EVALUATION SUMMARY: TWO UNOPENED SAMPLES FROM THE REPRESENTATIVE LOT WERE SUBMITTED FOR EVALUATION. THE SAMPLES WERE EVALUATED BY CAREFUSION QUALITY PERSONNEL AND NO ISSUES WERE OBSERVED. THIS INCLUDES ATTACHING THE PRODUCT TO THE FLOWMETER AND A THREAD TEST. IN ADDITION, THE CAP SCREWED ONTO BOTTLE WITH NO ISSUES ON BOTH SAMPLES RECEIVED. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. IN ADDITION, NO ISSUES WERE FOUND DURING REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. A REVIEW OF DATA TREND ANALYSIS REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED WITH THIS PRODUCT. BASED ON THE INVESTIGATION RESULTS, THE MOST PROBABLE CAUSE FOR THE ISSUE REPORTED COULD RESULT IF THE NUT OF THE PRODUCT IS NOT PROPERLY ATTACHED TO THE FLOW METER/OXYGEN INPUT AS THIS MAY CAUSE A POOR/INCORRECT FIT AND DAMAGE THE THREADS. IN ADDITION, IF THE CAP IS NOT SECURELY TIGHTENED, THIS MAY CAUSE AN IMPROPER CAP SEAL. UPON REVIEW OF THE INSTRUCTIONS FOR USE (IFU) OF THIS PRODUCT, IT IS STATED THAT: 1.FILL THE HUMIDIFIER JAR TO THE MAXIMUM FILL LINE WITH STERILE WATER. 2.TIGHTEN CAP SECURELY TO BOTTLE IN ORDER TO CREATE AN EFFECTIVE SEAL. 3.ATTACH THE WING NUT TO THE OXYGEN SOURCE 4.TEST FOR LEAKS AND PROPER FUNCTION OF PRESSURE RELIEF VALVE WHISTLE. APPLY GAS FLOW OF 3L/MIN. OCCLUDE O2 PORT AND LISTEN FOR ALARM WHISTLE. IF ALARM DOES NOT ACTIVATE, CHECK ALL CONNECTIONS FOR POSSIBLE LEAKS. 5.CONNECT SUPPLY TUBING (NOT INCLUDED) TO THE SMALL BARBED OUTLET CONNECTOR. 6.ADJUST OXYGEN FLOW AS DIRECTED BY PHYSICIAN. VERIFY THAT BUBBLES ARE PRESENT. CAREFUSION HIGHLY RECOMMENDS THAT THE INSTRUCTIONS FOR USE ARE FOLLOWED UPON PATIENT USE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: THE ITEM IS NOT SEALING PROPERLY.  ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013:  THE HUMIDIFIER DOES NOT WORK IF NOT THREADED ONTO O2 PORT CORRECTLY; IF CAP IS NOT SEALED CORRECTLY.  THE HUMIDIFIER STILL BUBBLES AND GIVES THE ILLUSION O2 IS COMING OUT. THIS HUMIDIFIER IS DIFFICULT TO SCREW ON TO WALL O2 AND DIFFICULT TO THREAD TO SEAL CAP.  THIS INCIDENT HAS HAPPENED TO ME TWO SEPARATE TIMES HOWEVER, SINCE I HAVE BECOME AWARE OF THE PROBLEM I HAVE HAD TO ADJUST SEVERAL UNITS TO ENSURE O2 IS DELIVERED TO PT. 3. NOT LONG TERM PATIENT HARM HOWEVER, A PATIENT WAS ADMITTED FOR 4-5HOURS AND SEVERAL DIFFERENT MASKS AND BIPAP WERE USED TO TRY TO CORRECT HYPOXIA BEFORE I NOTICED NO O2 WAS BEING DELIVERED. THE PT WAS ADMITTED TO CORRECT HYPOXIA. DEFINITELY NOT HELPING THE PATIENT FOR WHAT THEY WERE ADMITTED FOR. OUR MEDICAL DIRECTOR WAS PRESENT IN THE ROOM WHEN THE INCIDENT OCCURRED AND HE WAS VERY SURPRISED THIS COULD HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341258 HUMIDIFIER EMPTY 3 PSI WHITE CAP 50/CS HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT CAREFUSION 002003-A 0000531947

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention