BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2070065 · Received April 26, 2011

    Report

    Report Number
    9611451-2011-00266
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    March 29, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS PRESSURE TESTED AND VISUALLY INSPECTED FOR DAMAGE. RESULTS: THE PRESSURE TEST RESULT WAS OUTSIDE THE SPECIFICATION. FURTHER INSPECTION REVEALED A HOLE IN THE EVAQUA TUBE OF THE RETURNED BREATHING CIRCUIT. CONCLUSION: BASED ON THE EVALUATION OF RETURNED DEVICE, THE BREATHING CIRCUIT WAS PUNCTURED BY A BLUNT OBJECT, CREATING A HOLE AND RESULTING IN THE REPORTED DAMAGE. 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 COMPLAINT BREATHING CIRCUIT WAS PUNCTURED POST PRODUCTION. THE KEY DIFFERENCE BETWEEN FISHER & PAYKEL HEALTHCARE'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 (B)(4). 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 OBJECTS SUCH AS CIRCUIT HANGERS. THE RT240 USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENT: "VERIFY THAT VENTILATOR ALARMS ARE SET TO DETECT LOSS OF PRESSURE AND OVER PRESSURE", AS VENTILATOR ALARMS ALERT THE USER TO A LEAK IN THE SYSTEM AND ALLOWS CAREGIVERS TO ACT BY REPLACING THE BREATHING CIRCUIT ACCORDING TO THEIR STANDARD PROCEDURES. IT ALSO ADVISE THE USER TO "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE". (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. A HOLE IN THE EXPIRATORY TUBE WAS NOTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT240 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. A HOLE IN THE EXPIRATORY TUBE WAS NOTED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT240 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1