BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3895606 · Received June 25, 2014

    Report

    Report Number
    9611451-2014-00560
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 29, 2014
    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). THE COMPLAINT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. RESULTS: VISUAL INSPECTION OF DEVICE 1 (LOT DATE 6 AUGUST 2013) REVEALED THAT THERE WERE TWO HOLES IN THE EVAQUA LIMB OF THE CIRCUIT. THE FIRST HOLE WAS APPROXIMATELY 4.5 CM AWAY FROM THE PATIENT END CONNECTOR, AND THE SECOND WAS APPROXIMATELY 19 CM AWAY FROM THE PATIENT END CONNECTOR . A LOT CHECK REVEALED THREE OTHER SIMILAR COMPLAINTS FOR LOT DATE 130806. VISUAL INSPECTION OF DEVICE 2 (LOT DATE 10 DECEMBER 2013) REVEALED THAT THERE WAS A HOLE IN THE EVAQUA LIMB OF THE CIRCUIT APPROXIMATELY 1.5 CM AWAY FROM THE PATIENT END CONNECTOR . A LOT CHECK REVEALED ONE OTHER SIMILAR COMPLAINT FOR LOT DATE 131210. CONCLUSION: BASED ON OUR VISUAL INSPECTION, 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 THEY WERE RELEASED 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 OR BLUNT 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." HOSPITAL STAFF CORRECTLY CHECKED THE BREATHING CIRCUITS BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT TWO RT340 ADULT BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THEY FOUND THE EXPIRATORY LIMBS OF THE CIRCUITS WERE DAMAGED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT TWO RT340 ADULT BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THEY FOUND THE EXPIRATORY LIMBS OF THE CIRCUITS WERE DAMAGED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371377 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340

    Patients

    Seq Age Sex Outcome Treatment
    1