BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1640402 · Received March 18, 2010

    Report

    Report Number
    9611451-2010-00134
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 19, 2010
    Report Date
    February 19, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR SIGNS OF DAMAGE, SUCH AS HOLES OR TEARS. RESULTS: A 10MM LONG HOLE WAS FOUND IN THE EXPIRATORY EVAQUA BREATHING CIRCUIT LIMB. THE EDGE OF THE HOLE IS LACERATED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT # 090612. CONCLUSION: BASED ON THE TYPE OF DAMAGE, THE CIRCUIT WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. THE HOLE CAUSED THE BREATHING CIRCUIT TO FAIL THE LEAK TEST. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS PUNCTURED POST-PRODUCTION, POSSIBLY DURING STORAGE OR SET-UP. 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 EVAQUA EXPIRATORY TUBE HAS A PROTECTIVE MESH WHICH PREVENTS DAMAGE TO THE WALLS OF THE TUBE, HOWEVER, THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY SHARP OBJECTS AND CIRCUIT HANGERS. OUR USER INSTRUCTIONS ADVISE THE USER TO "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." WE HAVE RECEIVED TWO OTHER COMPLAINTS OF THIS TYPE IN THE PAST YEAR.

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REP THAT A RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS LEAKING AT THE Y-PIECE. THE REPORTED BREATHING CIRCUIT LEAK WAS FOUND PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT236 090612

    Patients

    Seq Age Sex Outcome Treatment
    1 MAQUET SERVO-I VENTILATOR