BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1918860 · Received December 9, 2010

    Report

    Report Number
    9611451-2010-00736
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Report Date
    November 12, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BREATHING CIRCUIT HAS NOT YET BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE FOR TESTING. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE CIRCUIT AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS (B)(4). METHOD: THE RETURNED BREATHING CIRCUIT WAS TESTED FOR BENT OR BROKEN HEATER WIRE PINS. RESULTS: ONE OF THE HEATER WIRE PINS ON THE INSPIRATORY LIMB OF THE BREATHING CIRCUIT WAS SPLIT, PREVENTING FULL INSERTION OF A HEATER WIRE ADAPTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 091209. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS POSSIBLE FOR THE USER TO BEND THE HEATER WIRE PINS DURING USE IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT DURING PRODUCTION OR BY THE END USER. DAMAGED PINS DO NOT PRECLUDE VENTILATION OF THE PATIENT, BUT PREVENT THE HEATING OF THE GAS DELIVERED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS (B)(4). METHOD: THE RETURNED BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A HOLE WAS FOUND IN THE CUFF OF A DRYLINE, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100722. CONCLUSION: IT IS LIKELY THAT THE HOLE IN THE DRYLINE CUFF WAS CAUSED BY DAMAGE DURING THE MOLDING PROCESS. THE USER INSTRUCTIONS PROVIDED WITH THE RT200 BREATHING CIRCUIT ADVISE THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WERE HOLES AT ONE OF AN RT200 BREATHING CIRCUIT. IT WAS REPORTED THAT THE HOLES CAUSED "AN IMPORTANT LEAK ESTIMATED AT (56%) OF THE VENTILATION." NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT200 BREATHING CIRCUIT HAD BENT HEATER WIRE PINS. THE BENT PINS WERE DISCOVERED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WERE HOLES AT ONE OF AN RT200 BREATHING CIRCUIT. IT WAS REPORTED THAT THE HOLES CAUSED "AN IMPORTANT LEAK ESTIMATED AT (56%) OF THE VENTILATION". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE RT200 100722

    Patients

    Seq Age Sex Outcome Treatment
    1