BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1941643 · Received December 29, 2010

    Report

    Report Number
    9611451-2010-00806
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 20, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT200 ADULT DUAL HEATED 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 K983112. BACKGROUND INFORMATION HMES (HEAT AND MOISTURE EXCHANGERS) ARE PASSIVE DEVICES THAT CONSERVE A PATIENT'S HEAT AND MOISTURE. THIS CONSERVATION TAKES PLACE BY CAPTURING AND RETAINING THE HEAT AND MOISTURE FROM A PATIENT'S EXPIRED BREATH AND THEN RELEASING IT INTO THE NEXT INSPIRED BREATH. HMES THEREBY HELP CREATE NORMAL CONDITIONS IN THE PATIENT'S AIRWAYS AND LUNGS, REDUCING THE RISK OF BREATHING COMPLICATIONS. HMES SHOULD NOT BE USED TOGETHER WITH ACTIVE HUMIDIFIERS OR NEBULIZERS. THE COMPLAINT RT200 ADULT BREATHING CIRCUIT WAS NOT RETURNED TO FPH FOR INVESTIGATION AND NO INFORMATION WAS RECEIVED THAT INDICATED THAT THE ADULT BREATHING CIRCUIT WAS FAULTY. FPH DOES NOT MANUFACTURE NOR DISTRIBUTE HME DEVICES. THE FPH USER INSTRUCTIONS THAT ACCOMPANY THE RT200 ADULT BREATHING CIRCUIT INDICATE IN PICTORIAL FORM THE CORRECT SET-UP AND CONNECTION OF THE BREATHING CIRCUIT TO A HUMIDIFIER. THE HOSPITAL CONFIRMED THAT THE REPORTED INCIDENT WAS DUE TO USER ERROR AS AN HME DEVICE WAS USED IN CONJUNCTION WITH A HUMIDIFIER AND THE RT200 BREATHING CIRCUIT. FURTHER INFORMATION RECEIVED FROM THE HOSPITAL CONFIRMED THAT THE PATIENT IS NOW IN GOOD CONDITION. NO FURTHER CONSEQUENCE TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. A PRODUCT MANAGER FROM THE FPH UK OFFICE IS CURRENTLY WORKING WITH THE HOSPITAL STAFF TO CARRY OUT A TRAINING SESSION TO REITERATE THE SET-UP INSTRUCTIONS FOR THE RT200 ADULT DUAL-HEATED BREATHING CIRCUIT. FPH HAS NOT RECEIVED COMPLAINTS OF ANY SIMILAR INCIDENTS FOR THIS PARTICULAR PRODUCT BEFORE.

    Additional Manufacturer Narrative · 1

    (B)(4).FISHER & PAYKEL HEALTHCARE'S EVALUATION OF THIS COMPLAINT IS CURRENTLY IN PROGRESS.WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) PRODUCT MANAGER THAT A CLINICIAN PLACED A HEAT AND MOISTURE EXCHANGER (HME) AT THE WYE-PIECE OF AN RT200 BREATHING CIRCUIT. IT WAS REPORTED THAT THE HME COLLECTED WATER, WHICH INCREASED THE FLOW RESISTANCE TO THE POINT THAT THE PATIENT, WHO WAS ON PRESSURE SUPPORT, ARRESTED. THE HOSPITAL HAS CONFIRMED THAT THE REPORTED INCIDENT WAS DUE TO USER ERROR.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE PRODUCT MANAGER THAT A CLINICIAN PLACE AN HME (HEAT AND MOISTURE EXCHANGER) AT THE WYE-PIECE OF AN RT200 BREATHING CIRCUIT. IT WAS REPORTED THAT THE HME COLLECTED WATER, WHICH INCREASED THE FLOW RESISTANCE TO THE POINT THAT THE PATIENT, WHO WAS ON PRESSURE SUPPORT, ARRESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT200 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening HEAT AND MOISTURE EXCHANGER (UNKNOWN MAKE, MODEL)