BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2480643 · Received March 6, 2012

    Report

    Report Number
    9611451-2012-00132
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    February 5, 2012
    Report Date
    February 6, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER. SEVERAL ATTEMPTS TO OBTAIN FURTHER INFORMATION WITH REGARD TO DEVICES, PATIENT, SET UP AND PHOTOGRAPHS FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL. THE PHYSICIAN INVOLVED IN THE INCIDENT HAS INDICATED HE WILL NOT BE ABLE TO ANSWER ANY FURTHER QUESTIONS FROM US AS HE WILL NOT HAVE TIME. WITHOUT THE RETURN OF THE COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE "WATER" IN THE EXPIRATORY LIMB OBSERVED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THE SET UP, CURRENT PATIENT STATUS AND PHOTOGRAPHS FROM THE HEALTHCARE FACILITY. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE PATIENT EXPERIENCED AN INTERRUPTION OF VENTILATION. IT WAS ALLEGED THIS WAS DUE TO THE PRESENCE OF WATER IN THE EXPIRATORY LIMB OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT DURING USE WITH A BABYLOG 8000 VENTILATOR. IT WAS ALSO ALLEGED THIS LED TO THE PATIENT SUFFERING CARDIAC ARREST AND REQUIRING RESUSCITATION. THE HOSPITAL FURTHER REPORTED THAT THE WATER TRAP OF THE EXPIRATORY LIMB WAS "NOT LOCATED IN THE LOWER POSITION OF THE CIRCUIT".

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE PATIENT EXPERIENCED AN INTERRUPTION OF VENTILATION. IT WAS ALLEGED THIS WAS DUE TO THE PRESENCE OF WATER IN THE EXPIRATORY LIMB OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT DURING USE WITH A BABYLOG 8000 VENTILATOR. IT WAS ALSO ALLEGED THIS LED TO THE PATIENT SUFFERING CARDIAC ARREST AND REQUIRING RESUSCITATION. THE HOSPITAL FURTHER REPORTED THAT THE WATER TRAP OF THE EXPIRATORY LIMB WAS "NOT LOCATED IN THE LOWER POSITION OF THE CIRCUIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DRAGER BABYLOG 8000 VENTILATOR| DRAGER BABYLOG 8000 VENTILATOR