BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2863004 · Received December 10, 2012

    Report

    Report Number
    9611451-2012-00900
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A HOLE ON THE EXPIRATORY LIMB, APPROXIMATELY 24CM FROM THE PATIENT END CONNECTOR. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: BASED ON INSPECTION OF THE DAMAGE, IT IS LIKELY THAT THE EVAQUA EXPIRATORY LIMB WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT DURING USE. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. TO THIS NOTE, THE HOSPITAL HAS REPORTED THAT THE EXPIRATORY LIMB WAS PIERCED AFTER FOUR DAYS OF USE AND THAT THE VENTILATOR HAD ALARMED FOR LEAKS JUST AFTER THE PATIENT HAD BEEN BATHED. THE KEY DIFFERENCE BETWEEN THE EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY TUBE OF 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 REMAINS 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 SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: 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 EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS "PIERCED" AFTER FOUR DAYS OF USE. THE HOSPITAL FURTHER REPORTED THAT THE VENTILATOR ALARMED FOR LEAKS SOON AFTER THE PATIENT WAS BATHED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS "PIERCED" AFTER FOUR DAYS OF USE. THE HOSPITAL FURTHER REPORTED THAT THE VENTILATOR ALARMED FOR LEAKS SOON AFTER THE PATIENT WAS BATHED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1