BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3062239 · Received April 16, 2013

    Report

    Report Number
    9611451-2013-00280
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 19, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE EVAQUA EXPIRATORY LIMB WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION OF THE EVAQUA EXPIRATORY LIMB REVEALED A HOLE, ABOUT 65CM FROM THE PATIENT END CONNECTOR. THE EVAQUA LIMB APPEARED TO HAVE BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120709. CONCLUSION: WE WERE UNABLE TO DETERMINE HOW THE LIMB CAME TO BE DAMAGED; HOWEVER, IT IS LIKELY THAT THE USE OF THE SUBJECT BREATHING CIRCUIT BEYOND THE RECOMMENDED MAXIMUM DAYS OF USE HAD CONTRIBUTED TO THE REPORTED FAULT. THE KEY DIFFERENCE BETWEEN THE EVAQUA BREATHING CIRCUITS AND 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 VAPOUR FROM EXPIRED VENTILATORY GAS 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 NON-FPH CIRCUIT HANGERS. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 ADULT DUAL EVAQUA BREATHING CIRCUIT STATE: - "THIS PRODUCT IS INTENDED TO BE USED FOR A MAXIMUM OF 7 DAYS." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "SET APPROPRIATE VENTILATOR ALARMS." - "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A "LEAK ALARM SOUNDED" AFTER USING AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT ON A PATIENT FOR EIGHT DAYS. IT WAS FURTHER REPORTED THAT A PIN HOLE WAS FOUND ON THE EXPIRATORY TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162906 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 120709

    Patients

    Seq Age Sex Outcome Treatment
    1