BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 1906630 · Received November 23, 2010

    Report

    Report Number
    9611451-2010-00713
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE COMPLAINT EXPIRATORY LIMB AND ONE COMPLAINT BREATHING CIRCUIT KIT WAS RETURNED UNSEALED. BOTH WITH LOT NUMBER 100420. THE RETURNED COMPLAINT DEVICES WERE VISUALLY INSPECTED, PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: NO DAMAGES WERE OBSERVED ON THE COMPLAINT EXPIRATORY LIMB AND THE PRESSURE TEST FOUND THE PRESSURE DROP TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. THE VISUAL INSPECTION REVEALED NO DAMAGES TO THE RETURNED BREATHING CIRCUIT KIT. THE PRESSURE TEST FOUND THE PRESSURE DROP TO BE OUTSIDE THE SPECIFICATION FOR THIS PRODUCT, AND THE WATER BATH TEST IDENTIFIED THE LEAK TO BE AROUND THE SWIVEL OF THE BREATHING CIRCUIT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: BREATHING CIRCUITS ARE COMPOSED OF MANY PARTS, THEREFORE LEAKS CAN OCCUR AT ANY OF THE CONNECTIONS. THE TWO PARTS THAT MAKE UP THE Y-SWIVEL ARE HELD TOGETHER BY A SNAP-FIT, WHICH HAS SOME INHERENT LEAKAGE THAT IS DETECTED AND COMPENSATED FOR BY THE VENTILATOR. IT IS POSSIBLE THAT IF NOT PROPERLY LOCKED IN PLACE, THE LEAK AT THE SWIVEL JOINT CAN BE ENHANCED DURING TRANSPORT OR SETUP DESPITE HAVING PASSED THE LEAK TEST AT THE TIME OF PRODUCTION. ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION WITH REGARD TO THE COMPLAINT DEVICES. 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 ON THE (B)(6) 2010 AN RT236 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED A VENTILATOR LEAK TEST. SUBSEQUENTLY ON THE (B)(6) 2010, THE HOSPITAL REPORTED THAT ANOTHER RT236 ALSO FAILED THE VENTILATOR LEAK TEST. THE HOSPITAL FURTHER REPORTED THAT IN BOTH CASES WHEN THE CIRCUITS WERE CHANGED, THE TESTS WERE SUCCESSFUL. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT ON (B)(6) 2010 AN RT236 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED A VENTILATOR LEAK TEST. SUBSEQUENTLY, ON (B)(6) 2010, THE HOSPITAL REPORTED THAT ANOTHER RT236 ALSO FAILED THE VENTILATOR LEAK TEST. THE HOSPITAL FURTHER REPORTED THAT IN BOTH CASES WHEN THE CIRCUITS WERE CHANGED, THE TESTS WERE SUCCESSFUL. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236 100420

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR| SERVO-I VENTILATOR