BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 7998148 · Received October 23, 2018

    Report

    Report Number
    9611451-2018-00909
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    September 15, 2018
    Report Date
    September 24, 2018
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE RT319 ADULT B-ILEVEL CPAP 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. THE FOUR COMPLAINT RT017 EXHALATION PORTS AND ASSOCIATED RT319 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUITS WERE NOT AVAILABLE TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. WITHOUT THE RETURN OF THE COMPLAINT DEVICES, WE ARE UNABLE TO DETERMINE IF THE DEVICES HAD A MALFUNCTION WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. A RECURRING PIN GAUGE TEST AND VISUAL INSPECTION IS CONDUCTED ON THE RT017 EXHALATION PORT TO ENSURE THERE ARE NO OCCLUSIONS IN THE EXHALATION HOLES PRIOR TO RELEASE FOR DISTRIBUTION. ANY EXHALATION PORTS THAT FAIL THIS INSPECTION ARE DISCARDED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT319 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT INCLUDE THE FOLLOWING WARNINGS: · CHECK FOR OCCLUSIONS IN BOTH INSPIRATORY AND PRESSURE LINE BEFORE CONNECTING TO PATIENT. · DO NOT BLOCK OR SEAL THE VENT HOLES ON THE EXHALATION PORT. · APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH.

    Description of Event or Problem · 0

    A HOSPITAL IN GERMANY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT FOUR EVENTS INVOLVING TWO TRACHEOSTOMY PATIENTS HAD OCCURRED INVOLVING THE RT017 EXHALATION PORT OF THE RT319 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT REPORTEDLY BECOMING CLOGGED. F&P MADE INQUIRIES WITH THE HOSPITAL TO DETERMINE THE NATURE OF THE REPORTED EVENT/S. IN RESPONSE TO THIS, THE HOSPITAL REPORTED THAT ON THE (B)(6) 2018, A PATIENT COULD NOT PERFORM EXPIRATION AND BECAME UNSTABLE. F&P UNDERSTANDS THE EXHALATION PORT WAS DESCRIBED AS BEING TIGHT THROUGH SECRETIONS. F&P UNDERSTANDS THAT THE EXHALATION PORT WAS REPLACED AND AFTER TWO HOURS THE HOSPITAL REPORTED THAT A SIMILAR EVENT OCCURRED WITH THE SAME PATIENT. THE HOSPITAL ADDITIONALLY REPORTED THAT ON THE 24 SEPTEMBER 2018 ANOTHER PATIENT EXPERIENCED THE SAME SEQUENCE OF EVENTS AS ABOVE. THE HOSPITAL HAS CONFIRMED THAT BOTH PATIENTS ARE IN A STABLE CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT319 ADULT B-ILEVEL CPAP 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. THE COMPLAINT RT319 ADULT BI-LEVEL CPAP CIRCUIT IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION, HOWEVER WE HAVE SENT FURTHER QUESTIONS TO THE HOSPITAL TO OBTAIN FURTHER INFORMATION WITH REGARDS TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT FOUR EVENTS INVOLVING TWO TRACHEOSTOMY PATIENTS HAD OCCURRED INVOLVING THE RT017 EXHALATION PORT OF THE RT319 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT REPORTEDLY BECOMING CLOGGED. F&P MADE INQUIRIES WITH THE HOSPITAL TO DETERMINE THE NATURE OF THE REPORTED EVENT/S. IN RESPONSE TO THIS, THE HOSPITAL REPORTED THAT ON THE (B)(6) 2018 A PATIENT COULD NOT PERFORM EXPIRATION, BECAME UNSTABLE AND WAS BAGGED BY HAND. F&P UNDERSTANDS THE EXHALATION PORT WAS DESCRIBED AS BEING TIGHT THROUGH SECRETIONS. F&P UNDERSTANDS THAT THE EXHALATION PORT WAS REPLACED AND AFTER TWO HOURS THE HOSPITAL REPORTED THAT A SIMILAR EVENT OCCURRED WITH THE SAME PATIENT. THE HOSPITAL ADDITIONALLY REPORTED THAT ON THE (B)(6) 2018 ANOTHER PATIENT EXPERIENCED THE SAME SEQUENCE OF EVENTS AS ABOVE. THE HOSPITAL HAS CONFIRMED THAT BOTH PATIENTS ARE IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836166 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT319 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention