BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2232106 · Received September 1, 2011

    Report

    Report Number
    9611451-2011-00539
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT380 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) AS IT HAD BEEN DESTROYED BY THE HOSPITAL. RESULTS: THE HOSPITAL HAS COMMENTED THAT THE DRUG ILOPROST WAS BEING ADMINISTERED TO THE PATIENT AND WAS BEING NEBULIZED AT THE Y-PIECE. THEY FURTHER STATED THAT EVEN WHEN USING ILOPROST WITH REUSABLE CIRCUITS THEY HAVE A LOT OF TROUBLE WITH THE EXPIRATORY FILTERS CLOGGING UP AND THAT THEY SOMETIMES HAVE TO USE MANY FILTERS IN LINE TO PROTECT THE VENTILATOR. THEY ALSO STATED THAT THE DRUG IS QUITE STICKY. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE OBSERVED CONDENSATION, BUT IT IS POSSIBLE THAT THE USE OF ILOPROST REDUCED THE PERFORMANCE OF THE BREATHING CIRCUIT. ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER ILOPROST IS KNOWN TO BE VERY STICKY AND IS ALSO KNOWN FOR CLOGGING FILTERS. IT IS POSSIBLE THAT THE ILOPROST COATED THE INSIDE OF THE TUBING, THEREBY REDUCING THE EFFICACY OF THE CIRCUIT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT EXCESSIVE CONDENSATE WAS FOUND IN BOTH THE INSPIRATORY AND EXPIRATORY LIMBS OF AN RT380 BREATHING CIRCUIT AND DISCONNECTION WAS REQUIRED TO REMOVE THE CONDENSATE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380

    Patients

    Seq Age Sex Outcome Treatment
    1