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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT
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FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT Back to Search Results
Model Number RT202
Device Problem Disconnection (1171)
Patient Problem Low Oxygen Saturation (2477)
Event Date 09/06/2022
Event Type  Injury  
Event Description
A distributor reported, on behalf of healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that the dryline of a rt202 adult inspiratory heated breathing circuit had disconnected from chamber during use.It was reported that the patient desaturated, however the level and duration of desaturation was not provided.It was further reported that the patient passed away the next day.The healthcare facility indicated that there was no causal relationship between the patient death and the reported event.Further information has been requested from the healthcare facility regarding the sequence of events.
 
Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Method: the complaint (b)(4) adult inspiratory heated breathing circuit was requested, however was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information provided by the customer and our knowledge of the product.Results: it was reported that the dryline of a (b)(4) adult inspiratory heated breathing circuit had disconnected from the humidification chamber during use.It was reported that the patient desaturated, however the level and duration of desaturation was not provided.It was further reported that the patient passed away the next day.The healthcare facility indicated that there was no causal relationship between the patient death and the reported event.Simulation testing was conducted to replicate the set-up described in this complaint and used representative production test specimens.Our testing demonstrated that it was only possible to replicate a dryline disconnection under a specific set of abnormal conditions.These included the humidification chamber to dryline connection was not firmly connected, in combination with the ventilation pressure within the system far exceeding 8 kpa which is the maximum pressure limit specified for the mr290 humidification chamber.One way to replicate the increase in pressure was by fully blocking the nasal cannula prongs of the opt944 optiflow + adult nasal cannula attached to the rt202 adult inspiratory heated breathing circuit.Even with these specific set of abnormal conditions, a dryline disconnection was not able to be achieved consistently.The (b)(4) adult inspiratory heated breathing circuit dryline and humidification chamber connectors are designed to meet iso 5356-1 specifications.Although the exact date of manufacture of the complaint device was not able to be determined, manufacturing records confirmed that there were no non-conformances related to the specifications of these connectors.Conclusion: based on our testing, we were unable to definitively determine a root cause for the disconnection reported by this customer.However, on the basis of our test results, it would appear possible that during set-up the dryline had not been securely connected to the humidification chamber by the user, and in a scenario where there is excessive pressure within the system, it is possible that the dryline may disconnect.All rt202 adult inspiratory heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt202 adult inspiratory heated breathing circuit include a pictorial showing the instructions to set-up the breathing circuit correctly.It also includes the following: "maximum operating pressure - 8kpa."."check all connections are tight before use."."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."."ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient."."perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."."for use under the supervision of trained medical personnel.".In addition, the user instructions which accompany the opt944 optiflow + adult nasal cannula also states the following: "as appropriate for patient's condition, monitor for any disruptions to patient receiving flow."."select appropriate size.Prongs must not create a seal in the nares.A clear gap must be visible around each prong."."do not use with an air entrainer, to prevent loss of therapy."."failure to use the set-up described above can compromise performance and affect patient safety."."achievable flow rates may depend on individual patient and/or flow source.".
 
Event Description
A distributor reported, on behalf of healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that the dryline of a rt202 adult inspiratory heated breathing circuit had disconnected from chamber during use.It was reported that the patient desaturated, however the level and duration of desaturation was not provided.It was further reported that the patient passed away the next day.The healthcare facility indicated that there was no causal relationship between the patient death and the reported event.Further information has been requested from the healthcare facility regarding the sequence of events.
 
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Brand Name
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
Type of Device
BTT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534000
MDR Report Key15710007
MDR Text Key302795978
Report Number9611451-2022-00934
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K983112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT202
Device Catalogue NumberRT202
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; F&P OPT944 OPTIFLOW + ADULT NASAL CANNULA; F&P OPT944 OPTIFLOW + ADULT NASAL CANNULA; OA2060 O2 BLENDER; OA2060 O2 BLENDER
Patient Outcome(s) Required Intervention;
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