BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-HEATED ADULT BREATHING CIRCUIT

    MDR report key: 3326178 · Received September 5, 2013

    Report

    Report Number
    9611451-2013-00671
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Report Date
    August 6, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RETURNED: 5 X RT134; LOT 130312; DATE OF MANUFACTURE: 12 MARCH 2013. 4 X RT134; LOT 130327; DATE OF MANUFACURE: 27 MARCH 2013. ADDITIONAL INFORMATION: UPON RECEIVING THE DEVICES THE CORRECT LOT NUMBERS WERE NOTED. METHOD: A TOTAL OF NINE RT134 NON-HEATED ADULT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THE RETURNED CIRCUITS WERE PRESSURE TESTED AND SUBSEQUENTLY SUBMERGED IN A WATER BATH TO TEST FOR LEAK. RESULTS: PRESSURE TEST REVEALED THAT ALL OF THE RETURNED RT134 CIRCUITS EXHIBITED LEAK AND WERE OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAK WAS THROUGH THE CONNECTION BETWEEN THE WATER TRAP LID AND BOWL FOR ALL OF THE RETURNED RT134 CIRCUITS. A LOT CHECK REVEALED NO OTHER COMPLIANTS OF THIS NATURE FOR LOT NUMBERS 130312 AND 130327. CONCLUSION: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND A LID, WHICH CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED AFTER THE SUBJECT RT134 ADULT BREATHING CIRCUIT WAS RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT134 ADULT UNHEATED BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE ALARMS." THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND DETECTED THE LEAK DURING A SETUP CHECK AND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT134 NON-HEATED ADULT BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST AND THAT AN AIR LEAK WAS NOTED FROM THE WATER TRAP. THEY FURTHER REPORTED THAT THIS HAS HAPPENED PREVIOUSLY WITH SOME RT134 ADULT BREATHING CIRCUITS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN THAILAND REPORTED VIA OUR DISTRIBUTOR THAT AN RT134 NON-HEATED ADULT BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST AND THAT AN AIR LEAK WAS NOTED FROM THE WATER TRAP. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442038 NON-HEATED ADULT BREATHING CIRCUIT BZO BZO FISHER & PAYKEL HEALTHCARE LTD RT134 130312, 130327

    Patients

    Seq Age Sex Outcome Treatment
    1