BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3588630 · Received January 22, 2014

    Report

    Report Number
    9611451-2014-00056
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 27, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). LOT NUMBER: 130806, MANUFACTURING DATE: 08/06/2013, QUANTITY AFFECTED: 1. LOT NUMBER: UNKNOWN, MANUFACTURING DATE: UNKNOWN, QUANTITY AFFECTED: 1. METHOD: THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THE EVAQUA EXPIRATORY LIMB WITH LOT NUMBER 130806 SUSTAINED A HOLE ABOUT 10CM FROM THE PATIENT END CONNECTOR. THE ONE WITH UNKNOWN LOT NUMBER ALSO SUSTAINED A HOLE ABOUT 2.5CM FROM THE ELBOW CONNECTOR. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 130806. CONCLUSION: BASED ON THE INSPECTION CONDUCTED, THE SUBJECT EVAQUA 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 ANY OF THESE TESTS 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 THEY WERE RELEASED FOR DISTRIBUTION. 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 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT TWO RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS FAILED THE LEAK TEST. A DAMAGE WAS OBSERVED ON THE EXPIRATORY LIMBS, CAUSING THE REPORTED LEAKS. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51459 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1