BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1622148 · Received March 2, 2010

    Report

    Report Number
    9611451-2010-00103
    Event Type
    Other
    Date Received
    March 2, 2010
    Date of Event
    February 14, 2010
    Report Date
    February 23, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FISHER & PAYKEL HEALTHCARE ('FPH') RECEIVED THIS COMPLAINT FROM A HEALTHCARE FACILITY IN (B)(6). THE RT340 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA WITH A 510(K) OF K983112. FPH HAS REQUESTED THAT BOTH COMPLAINT RT340 BREAKING CIRCUITS BE RETURNED TO FPH IN (B)(4) FOR INVESTIGATION INTO A POSSIBLE ROOT CAUSE OF THE COMPLAINT AS REPORTED. TO FURTHER ASSIST IN OUR FINAL ANALYSIS, WE HAVE ALSO MADE A REQUEST FOR ADDITIONAL INFO RELATING TO THE CIRCUMSTANCES SURROUNDING THE EVENT AND USE OF THE MEDICAL DEVICE AS WELL AS CLARIFICATION OF THE PT'S STATUS AS A RESULT OF THE INCIDENT. WE ARE CURRENTLY AWAITING RECEIPT OF THE COMPLAINT DEVICES AND A RESPONSE TO OUR REQUEST FOR CLARIFICATION. AT PRESENT, WE ARE UNABLE TO PROVIDE THE RESULTS OF AN ANALYSIS INTO THIS INCIDENT. THE KEY DIFFERENCE BETWEEN FPH'S EVAQUA BREATHING CIRCUITS AND THE CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY TUBE OF EVAQUA CIRCUITS SUCH AS THE RT340 IS COMPOSED OF A THIN, SEMI-PERMEABLE FILM SPECIALLY DESIGNED TO ALLOW WATER VAPOR FROM EXPIRED VENTILATORY GASES TO PASS THROUGH. THE EXPIRATORY TUBE OF AN EVAQUA BREATHING CIRCUIT INCORPORATES AS A PROTECTIVE MESH TO PREVENT DAMAGE TO THE WALLS OF THE TUBE DURING USE. NONETHELESS, THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR TO DAMAGE CAUSED BY SHARP OBJECTS AND CIRCUIT HANGERS. WE WILL PROVIDE OUR CONCLUSION AND FURTHER COMMENTS AT THE CONCLUSION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE ('FPH') REP THAT THE EXPIRATORY TUBE OF AN RT340 DUAL-HEATED EVAQUA BREATHING CIRCUIT ('THE BREATHING CIRCUIT') DEVELOPED A LEAK IN THE REGION OF THE Y-CONNECTOR AFTER A FEW DAYS OF USE. THE HEALTHCARE FACILITY FURTHER ADVISED FPH THAT AS A RESULT OF THE LEAK, THE PT EXPERIENCED A DESATURATION OF BLOOD OXYGEN LEVELS. ATTENDING MEDICAL STAFF IMMEDIATELY REPLACED THE BREATHING CIRCUIT. HOWEVER, IT APPEARED THAT THE REPLACEMENT BREATHING CIRCUIT ALSO PRESENTED A SIMILAR LEAK WHICH WAS DETECTED UPON INITIAL SET-UP. NO FURTHER PT CONSEQUENCE OCCURRED AS A RESULT OF THE SUBSEQUENT LEAK. FPH HAS MADE A REQUEST FOR THE RETURN OF BOTH COMPLAINT BREATHING CIRCUITS IN ORDER TO CONDUCT AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT340 100106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention