BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CIRCUIT KIT

    MDR report key: 2960110 · Received February 13, 2013

    Report

    Report Number
    9611451-2013-00091
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT224 INFANT BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT224 INFANT BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. METHOD: THE FISHER & PAYKEL EQUIPMENT INCLUDED IN THE SET-UP HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) FOR EVALUATION DESPITE MULTIPLE REQUESTS. THEREFORE OUR INVESTIGATION IS BASED ON THE LIMITED INFORMATION PROVIDED BY THE HOSPITAL, OUR INVESTIGATION OF PREVIOUS SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE FISHER & PAYKEL PRODUCTS IN THE SET-UP. COMMENTS: AS REPORTED ABOVE, IT APPEARS THAT NEITHER THE CHAMBER END NOR PATIENT END TEMPERATURE PROBES WERE INITIALLY PLUGGED IN. THE USER INSTRUCTIONS FOR THE MR850 RESPIRATORY HUMIDIFIER WARN AGAINST OPERATING THE MACHINE WHEN THE TEMPERATURE PROBES ARE NOT CORRECTLY AND SECURELY FITTED. THE HOSPITAL'S REPORT INDICATES THAT WHEN IT WAS FIRST RECOGNISED THAT THE CHAMBER END TEMPERATURE PROBE WAS UNPLUGGED, THE TEMPERATURE ON THE HUMIDIFIER READ AS 23°C. ONCE THE NURSES RECONNECTED THE TEMPERATURE PROBES THE TEMPERATURE ON THE HUMIDIFIER READ AS 37°C. THE REPORTS FROM THE HOSPITAL ALSO INDICATE THAT NO ALARMS WERE NOTICED. THIS WOULD INDICATE THAT THE TEMPERATURE WAS NOT HIGH ENOUGH TO CAUSE INJURY. FOLLOWING CORRECTION OF THE SET UP ISSUES, THE TEMPERATURE ON THE HUMIDIFIER READ AS 37°C, SUGGESTING THE HUMIDIFIED AIR WAS BEING DELIVERED AT THE APPROPRIATE TEMPERATURE. BASED ON THE INFORMATION PROVIDED IN THE HOSPITAL'S REPORTS, THERE IS NOTHING TO SUGGEST THAT THE FISHER & PAYKEL HEALTHCARE EQUIPMENT CAUSED OR CONTRIBUTED TO THE REPORTED INJURY. WE NOTE THAT THE PRECISE NATURE OF THE INJURY IS NOT CLEAR FROM THE REPORTS. THE LATEST DESCRIPTION OF THE INJURY WAS THAT IT WAS MORE LIKE A HEMATOMA. HEMATOMA'S ARE USUALLY CAUSED BY APPLIED PHYSICAL PRESSURE. OUR PRODUCTS WERE NOT IN PHYSICAL CONTACT WITH THE PATIENT AND COULD NOT EXERT PHYSICAL PRESSURE ON THE NOSE THAT WOULD CAUSE THE REPORTED INJURY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED AN INCIDENT INVOLVING A PREMATURE INFANT ON A SET-UP INCLUDING A FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIER, FISHER & PAYKEL HEALTHCARE RT224 INFANT CONTINUOUS BREATHING CIRCUIT AND CAREFUSION INFANT FLOW LP SYSTEM MASK. AFTER APPROXIMATELY FOUR HOURS OF THERAPY, HOSPITAL STAFF REPORTEDLY NOTED THAT THE INFANT'S SKIN WAS RED. AFTER A FURTHER 1.5 HOURS OF THERAPY, HOSPITAL STAFF REPORTEDLY NOTED THAT THE INFANT'S NOSE WAS RED AND "LOOKS LIKE BURN MARK". TWO DAYS LATER, THE NOSE WAS DESCRIBED AS "DRY AND LOOKS LIKE THIS IS A HEMATOMA". IT WAS ALSO REPORTED THAT HOSPITAL STAFF NOTICED IN THE FIRST HOUR OF THERAPY THAT THE TEMPERATURE / FLOW PROBE WAS NOT PLUGGED IN AND WAS "HANGING FREE IN THE ROOM". IT IS NOT CLEAR WHETHER THE STAFF TOOK ANY CORRECTIVE ACTION REGARDING THE PROBE. THE HOSPITAL FURTHER REPORTED THAT THE BABY WAS BORN AT (B)(6) AND WAS INTUBATED NASALLY.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) HAS REPORTED AN INCIDENT INVOLVING A PREMATURE INFANT ON A SET-UP INCLUDING A FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIER, FISHER & PAYKEL HEALTHCARE RT224 INFANT CONTINUOUS BREATHING CIRCUIT AND A CAREFUSION INFANT FLOW LP SYSTEM NASAL INTERFACE. ONE OF THE HOSPITAL'S REPORTS ALSO MENTIONED THAT AN RT132 INFANT BREATHING CIRCUIT WAS USED INSTEAD OF THE RT224, BUT NO CONFIRMATION OF THIS HAS BEEN RECEIVED. THE REPORTS WE HAVE RECEIVED FROM THE HOSPITAL ARE LIMITED, CONFLICT EACH OTHER IN PLACES AND DO NOT HAVE SUFFICIENT DETAIL FOR US TO DRAW A CONCLUSION. (B)(6), THE (B)(6) ARRIVED IN THE RELEVANT DEPARTMENT OF THE HOSPITAL, AND WAS PLACED ON THE ABOVE SET-UP. AFTER APPROXIMATELY FOUR HOURS OF THERAPY, HOSPITAL STAFF REPORTEDLY NOTED THAT THE (B)(6) SKIN WAS RED. AFTER FIVE AND A HALF HOURS OF THERAPY, HOSPITAL STAFF REPORTEDLY NOTED THAT THE (B)(6) NOSE WAS RED, AND THE EPIDERMIS "IS DAMAGED AND IS PEELING". THE (B)(6) NOSE WAS WASHED WITH NACL AND MEPITEL, AND TREATMENT WAS CONTINUED. IT WAS REPORTED THAT THE "NOSE IS LIKE BURNED" IT WAS REPORTED THAT (B)(6) REQUIRED INTENSIVE CARE AND WAS INTUBATED NASALLY WITH A VYGON NASOGASTRIC FEEDING TUBE. TWO DAYS LATER, THE NOSE WAS DESCRIBED AS "DRY AND LOOKS LIKE THIS IS A HEMATOMA". IT APPEARS FROM THE HOSPITAL'S REPORT THAT NEITHER THE CHAMBER OR THE PATIENT ENDS OF THE TEMPERATURE PROBE WERE PLUGGED IN UPON COMMENCEMENT OF THERAPY WITH THE FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIER. THIS CORRECT SET UP IS REQUIRED FOR THE SAFE AND EFFECTIVE USE OF OUR THERAPY AND IS INDICATED IN THE USER INSTRUCTIONS. THE HOSPITAL'S REPORTS SUGGEST THAT AFTER 15 MINUTES IT WAS IDENTIFIED THAT THE CHAMBER END TEMPERATURE PROBE WAS UNPLUGGED AND THE TEMPERATURE WAS SHOWING AS 23°C, AND THAT THE PATIENT END TEMPERATURE PROBE WAS IDENTIFIED AS UNPLUGGED AT A LATER TIME (BETWEEN 40 MINUTES AND ONE HOUR FOLLOWING COMMENCEMENT OF THERAPY). IT IS UNCLEAR EXACTLY WHEN THE NURSES RECONNECTED THE TEMPERATURE PROBES, ALTHOUGH THE REPORT DOES INDICATE THAT THIS WAS DONE AT SOME POINT, BECAUSE ONCE THE TEMPERATURE PROBES WERE PLUGGED IN THE TEMPERATURE ON THE HUMIDIFIER WAS RECORDED AS 37°C. THIS WOULD INDICATE THAT THE TEMPERATURE WAS NOT HIGH ENOUGH TO CAUSE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63532 INFANT CIRCUIT KIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT224 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CAREFUSION INFANT FLOW LP SYSTEM MASK| CAREFUSION INFANT FLOW LP SYSTEM NASAL INTERFACE| MR850 RESPIRATORY HUMIDIFIER| MR850 RESPIRATORY HUMIDIFIER| VYGON NASOGASTRIC FEEDING TUBE