BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3834057 · Received May 27, 2014

    Report

    Report Number
    9611451-2014-00472
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 7, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT212 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT 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 K983112. METHOD: THE FIVE COMPLAINT RT212 BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. DEVICES TWO TO FIVE OF THE CIRCUITS WERE FROM LOT 140210 (MANUFACTURED 10 FEB 2014) AND DEVICE ONE WAS FROM LOT 131210 (MANUFACTURED 10 DEC 2013). DEVICES 1 AND 2 WERE RETURNED UNSEALED, WHILE DEVICES 3, 4 AND 5 WERE STILL SEALED IN THEIR ORIGINAL PACKAGING. THE CIRCUITS WERE VISUALLY INSPECTED. RESULTS: DEVICE1: A CUT WAS FOUND IN THE INSPIRATORY LIMB, ABOUT 35 CM FROM THE ELBOW. DEVICE 2: A CUT WAS FOUND IN THE INSPIRATORY LIMB, ABOUT 34 CM FROM THE ELBOW. DEVICES 3-5: A CUT WAS FOUND IN EACH OF THE PACKAGING BAGS AND EACH OF THE INSPIRATORY LIMBS WERE FOUND TO BE SCRATCHED. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE RELATED LOT NUMBERS. CONCLUSION: THE DAMAGE TO THE BREATHING CIRCUITS AND TO THE CIRCUIT PACKAGING APPEARED TO HAVE BEEN CAUSED BY A SHARP OBJECT. IT IS MOST LIKELY THAT THE CIRCUITS BAGS WERE OPENED WITH A KNIFE OR BOXCUTTER AND THE CIRCUITS INADVERTENTLY DAMAGED. THE BREATHING CIRCUITS ARE PACKAGED IN BOXES OF TEN AND EACH BOX CARRIES A WARNING AGAINST USE OF A SHARP OBJECT WHEN OPENING THE PACKAGING. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE DAMAGE OCCURRED AFTER THE PRODUCTS WERE RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT212 ADULT INSPIRATORY HEATED 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 VENTILATOR ALARMS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT FIVE RT212 ADULT BREATHING CIRCUITS FAILED THE LEAK TEST ON A SERVO VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311472 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT212 140210

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO VENTILATOR