BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 4770489 · Received May 14, 2015

    Report

    Report Number
    9611451-2015-00241
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 17, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. ONE CIRCUIT WAS FROM LOT 130729 (DATE OF MANUFACTURE: 29 JULY 2013) AND THE OTHER CIRCUIT WAS FROM LOT 140407 (DATE OF MANUFACTURE: 07 APRIL 2014). DUE TO THE RECENT CONFIRMED CASES IN (B)(6) OF THE VIRUS THAT CAUSES (B)(6) AND THE RISK OF INFECTION, THE RETURNED RT340 BREATHING CIRCUITS WERE ONLY VISUAL INSPECTED THROUGH THE SEALED BAG. THEREFORE, OUR INVESTIGATION WAS BASED ON THE FINDINGS OF OUR VISUAL INSPECTION AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION DID NOT IDENTIFY ANY DAMAGE TO THE RETURNED BREATHING CIRCUITS. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE LEAK REPORTED BY THE CUSTOMER AS NO VISIBLE FAULT WAS FOUND WITH THE RETURNED BREATHING CIRCUITS. HOWEVER, DUE TO THE OUTBREAK OF (B)(6) IN (B)(6) AND THE POTENTIAL RISK OF INFECTION, WE CANNOT COMPLETE OUR INVESTIGATION. ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE KEY DIFFERENCE BETWEEN FPH'S EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY LIMB OF THE 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 OR BLUNT OBJECTS AND NON-FPH CIRCUIT HANGERS. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. SET APPROPRIATE VENTILATOR ALARMS. THE HOSPITAL STAFF CORRECTLY CHECKED THE CIRCUITS PRIOR TO PATIENT USE. THIS IS IN LINE WITH OUR USER INSTRUCTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE TWO COMPLAINT RT340 BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A LEAK WAS FOUND ON THE EXPIRATORY CIRCUIT OF TWO RT340 ADULT BREATHING CIRCUITS. THIS WAS FOUND DURING THE VENTILATOR LEAK TEST BEFORE PATIENT USE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A LEAK WAS FOUND ON THE EXPIRATORY CIRCUIT OF TWO RT340 ADULT BREATHING CIRCUITS. THIS WAS FOUND DURING THE VENTILATOR LEAK TEST BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316345 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 130729

    Patients

    Seq Age Sex Outcome Treatment
    1