BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3867693 · Received June 11, 2014

    Report

    Report Number
    9611451-2014-00502
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 15, 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). METHOD: THE TWO COMPLAINT RT340 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF DEVICE 1, LOT DATE 140227 ((B)(6) 2014) REVEALED THAT THE EVAQUA EXPIRATORY LIMB HAD A HOLE APPROXIMATELY 3.5 CM FROM THE PATIENT END CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT DATE 140227. VISUAL INSPECTION OF DEVICE 2, LOT DATE 140207 ((B)(6) 2014) REVEALED THAT THE EVAQUA EXPIRATORY LIMB HAD A HOLE APPROXIMATELY 4 CM FROM THE PATIENT END CONNECTOR. A LOT CHECK REVEALED TWO OTHER SIMILAR COMPLAINTS FOR LOT DATE 140207. CONCLUSION: BASED ON OUR VISUAL INSPECTION, THE SUBJECT EXPIRATORY LIMBS APPEAR 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 AND 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."

    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 LIMB OF THE CIRCUITS WERE DAMAGED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346076 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340

    Patients

    Seq Age Sex Outcome Treatment
    1