BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2900456 · Received January 7, 2013

    Report

    Report Number
    9611451-2013-00013
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) OF EVALUATION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR THE REPORTED LEAK. RESULTS: VISUAL INSPECTION REVEALED A PUNCTURED HOLE ON THE EXPIRATORY LIMB APPROXIMATELY 1MM X 2MM LOCATED 67CM FROM THE PROXIMAL CONNECTOR. THE PRESSURE TEST REVEALED THAT THE RETURNED BREATHING CIRCUIT EXHIBITED SIGNIFICANT LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120601. CONCLUSION: THE DAMAGE TO THE EVAQUA EXPIRATORY LIMB INDICATES THAT IT WAS PUNCTURED BY A SHARP OBJECT. ALL RT236 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAK PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THE SUBJECT RT236 INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE AFFECTED BREATHING CIRCUIT WAS DAMAGED POST PRODUCTION. THE EXPIRATORY TUBE OF EVAQUA CIRCUITS IS COMPOSED OF A THIN, SEMI-PERMEABLE FILM SPECIALLY DESIGNED TO ALLOW WATER VAPOR FROM EXPIRED VENTILATORY GASES TO PASS THROUGH. THIS TECHNOLOGY WAS DEVELOPED TO OVERCOME CONDENSATE-RELATED ISSUES ASSOCIATED WITH CONVENTIONAL BREATHING CIRCUITS. THE EXPIRATORY TUBE OF AN EVAQUA BREATHING CIRCUIT INCORPORATES 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. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT236 INFANT BREATHING CIRCUIT STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "USE CAUTION WHEN POSITIONING THE CIRCUIT. SHARP OR HARSH EDGES AND SURFACES MAY DAMAGE THE EXPIRATORY LIMB." "SET APPROPRIATE VENTILATOR ALARMS."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS 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 HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A HOLE WAS IDENTIFIED ON THE EXPIRATORY LIMB OF AN RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A HOLE WAS IDENTIFIED ON THE EXPIRATORY LIMB OF AN RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7162 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236 120601

    Patients

    Seq Age Sex Outcome Treatment
    1