BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3771228 · Received April 24, 2014

    Report

    Report Number
    9611451-2014-00368
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 26, 2014
    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

    METHOD: THE TWO COMPLAINT RT340 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) AND WERE VISUALLY INSPECTED. ONE CIRCUIT WAS FROM LOT 131104, MANUFACTURED 4 NOV 2013. THE OTHER CIRCUIT WAS FROM LOT 140207, MANUFACTURED 7 FEB 2014. RESULTS: VISUAL INSPECTION REVEALED THAT BOTH EVAQUA EXPIRATORY LIMBS HAD A HOLE IN THE TUBING. ONCE LIMB HAD A HOLE NEXT TO THE PROXIMAL CONNECTOR AND ONE HAD A HOLE 10CM FROM THE PROXIMAL CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBERS PROVIDED. CONCLUSION: BASED ON THE INSPECTION CONDUCTED, THE SUBJECT EXPIRATORY LIMBS APPEARED TO HAVE BEEN PUNCTURED WITH A BLUNT OBJECT. ALL RT340 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS IS DISCARDED. IN ADDITION, TUBE WEIGHING AND BOND STRENGTH TESTING ARE PERFORMED EVERY 15 MINUTES. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THIS SUGGESTS THAT THE SUBJECT BREATHING CIRCUITS WERE DAMAGED AFTER RELEASE FOR DISTRIBUTION. THE KEY DIFFERENCE BETWEEN THE 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 CAN BE 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 THAT ACCOMPANY THE RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: - 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE 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 VIA A DISTRIBUTOR THAT TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE LEAK TEST PRIOR TO PATIENT USE. THEY FURTHER REPORTED THAT THE EXPIRATORY LIMBS WERE DAMAGED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE LEAK TEST PRIOR TO PATIENT USE. THEY FURTHER REPORTED THAT THE EXPIRATORY LIMBS WERE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250238 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 131104;140207

    Patients

    Seq Age Sex Outcome Treatment
    1