BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2990384 · Received March 5, 2013

    Report

    Report Number
    9611451-2013-00158
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 4, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT380 ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. ONE COMPLAINT RT380 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE(B)(4) FOR EVALUATION. OUR INVESTIGATION IS CURRENTLY IN PROGRESS AND WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE COMPLAINT RT380 BREATHING CIRCUIT FROM THE FIRST INCIDENT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT RT380 DEVICE. WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT FOR THE FIRST INCIDENT. WITHOUT THE COMPLAINT DEVICE, WE WERE UNABLE TO CONFIRM THE REPORTED FAULT FOR THE SECOND INCIDENT. ADDITIONAL COMMENTS: THE COMPLAINT RT380 CIRCUIT FROM THE FIRST INCIDENT WAS RETURNED WITH THE INSPIRATORY ELBOW TAPED TO THE CHAMBER PORT. AFTER REMOVING THE TAPE, VISUAL INSPECTION OF THE COMPLAINT RT380 DEVICE REVEALED THAT NO DAMAGE OR DEFORMATION WAS FOUND ON THE RT380 INSPIRATORY ELBOW OR ON THE CHAMBER PORT. BOTH COMPLAINT RT380 BREATHING CIRCUITS WERE REPORTED TO HAVE PASSED THE TEST DURING SETUP. THE PATIENT WAS ABLE TO USE THE FIRST COMPLAINT RT380 CIRCUIT FOR SEVERAL DAYS PRIOR TO THE FIRST INCIDENT, AND THE SECOND COMPLAINT RT380 CIRCUIT WAS USED FOR ONE DAY PRIOR TO THE SECOND INCIDENT. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 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." OUR REGIONAL OFFICE IN (B)(4) HAD REMINDED THE HOSPITAL TO CHECK THAT ALL CONNECTIONS ARE TIGHT BEFORE USE AS PER OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN FRANCE REPORTED THAT THE INSPIRATORY LIMB OF TWO RT380 BREATHING CIRCUITS HAD DISCONNECTED FROM THE WATER CHAMBER DURING USE ON THE SAME PATIENT. DURING USE OF THE FIRST DEVICE ON (B)(6) 2013, PATIENT WAS ALLEGED TO HAVE OXYGEN DESATURATION AND CARDIAC ARREST. CARDIAC MASSAGE WAS PERFORMED BY THE MEDICAL STAFF AND THE PATIENT WAS THEN VENTILATED MANUALLY. THE CIRCUIT WAS THEN RECONNECTED. DURING USE OF THE SECOND DEVICE ON (B)(6) 2013, PATIENT WAS ALLEGED TO HAVE OXYGEN DESATURATION TO 85%. THE CIRCUIT WAS RECONNECTED AND NO FURTHER CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE INSPIRATORY LIMB OF TWO RT380 BREATHING CIRCUITS HAD DISCONNECTED FROM THE WATER CHAMBER IN TWO DIFFERENT INCIDENTS DURING USE ON THE SAME PATIENT. DURING USE OF THE FIRST DEVICE ON (B)(6) 2013, PATIENT WAS ALLEGED TO HAVE OXYGEN DESATURATION AND CARDIAC ARREST. CARDIAC MASSAGE WAS PERFORMED BY THE MEDICAL STAFF AND THE PATIENT WAS THEN VENTILATED MANUALLY. THE CIRCUIT WAS THEN RECONNECTED. DURING USE OF THE SECOND DEVICE ON (B)(6) 2013, PATIENT WAS ALLEGED TO HAVE OXYGEN DESATURATION TO 85%. THE CIRCUIT WAS RECONNECTED AND NO FURTHER CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94132 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention