BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECARE HUMIDIFIER

    MDR report key: 2002019 · Received February 27, 2011

    Report

    Report Number
    9611451-2011-00102
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Report Date
    January 31, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K953392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT HC500JHU HOMECARE HUMIDIFIER AND THE ASSOCIATED BREATHING CIRCUITS HAVE NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. OUR ANALYSIS IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND THE PATIENT'S MOTHER. RESULTS: INFORMATION RECEIVED FROM THE HOSPITAL AND THE PATIENT'S MOTHER REVEALED THAT THE REPORTED BREATHING CIRCUITS USED WITH THE HC500JHU HUMIDIFIER THAT MELTED WERE MANUFACTURED BY CAREFUSION. IT WAS FURTHER REPORTED THAT "EXCESS CONDENSATION" WAS OBSERVED WHILE THE BREATHING CIRCUITS WERE BEING USED ON THE PATIENT. THE MOTHER OF THE PATIENT ALSO CONFIRMED, THROUGH THE LETTER THAT SHE SENT TO THE HOSPITAL, THAT THEY ALWAYS HAVE THE "TOP 2/3 OF THE CIRCUIT UNDER THE BEDDING. HOWEVER, THE CIRCUIT INSERT "CLEARLY STATES NOT TO COVER ANY PORTION OF THE CIRCUIT." CONCLUSION: CONDENSATE IN THE HUMIDIFICATION SYSTEM, ALTHOUGH NOT PREFERRED, IS AN EXPECTED SIDE EFFECT OF HEATED PASS-OVER HUMIDIFICATION SYSTEMS IN MANY CONDITIONS, AND MAY VARY BETWEEN LIGHT MISTING TO WATER DROPLETS THAT FORM ON THE WALL OF COOL BREATHING CIRCUIT TUBING. THERE ARE MANY FACTORS WHICH CAN RESULT IN CONDENSATION BUILD UP. THESE INCLUDE EQUIPMENT SET UP ERRORS, SUCH AS INCORRECT POSITIONING OF THE BREATHING CIRCUIT, OR EFFECTS OF ENVIRONMENTAL FACTORS (E.G. AIR CONDITIONING). IT IS ADVISED THAT WHEN SETTING UP HUMIDIFIED BREATHING CIRCUITS ENSURE THAT THE INSTRUCTIONS FOR USE ARE FOLLOWED AND THAT THE LOCAL ENVIRONMENT IS CONSIDERED. THE FISHER & PAYKEL HC500 RESPIRATORY HUMIDIFIER IS DESIGNED FOR USE WITH ARTIFICIAL VENTILATION SYSTEMS. THE DEVICE USER INSTRUCTIONS PROVIDE THE FOLLOWING WARNINGS: USE ONLY FISHER & PAYKEL APPROVED CHAMBERS, CIRCUITS AND ACCESSORIES. PERFORMANCE AND SAFETY CANNOT BE GUARANTEED IF OTHER TYPES OF ACCESSORIES ARE USED. DO NOT COVER THE PATIENT DELIVERY TUBE WITH BLANKETS, TOWELS OR SIMILAR MATERIAL AS THIS MAY CAUSE THE PATIENT DELIVERY TUBE TO OVERHEAT. TO PREVENT THE POSSIBILITY OF ACCIDENTAL PATIENT BURNS, ENSURE THAT THE HEATED BREATHING CIRCUIT IS NOT IN CONTACT WITH THE PATIENT'S SKIN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT (B)(4) HOMECARE HUMIDIFIER IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL FOR INVESTIGATION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE RECEIVE FURTHER INFORMATION AND HAVE COMPLETED OUR ANALYSIS.

    Description of Event or Problem · 1

    A PATIENT'S MOTHER REPORTED TO A RESPIRATORY THERAPIST IN PEYTON MANNING CHILDREN'S HOSPITAL THAT THEIR (B)(4) HOMECARE HUMIDIFIER "CAUSED SEVERAL BREATHING CIRCUITS TO BE MELTED". IT WAS FURTHER REPORTED THAT EXCESS CONDENSATION OCCURRED IN THE BREATHING CIRCUITS DURING USE.

    Description of Event or Problem · 1

    A PATIENT'S MOTHER REPORTED TO A RESPIRATORY THERAPIST IN (B)(6) THAT THEIR HC500JHU HOMECARE HUMIDIFIER "CAUSED SEVERAL BREATHING CIRCUITS TO BE MELTED". IT WAS FURTHER REPORTED THAT EXCESS CONDENSATION OCCURRED IN THE BREATHING CIRCUITS DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECARE HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED HC500JHU

    Patients

    Seq Age Sex Outcome Treatment
    1