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A healthcare facility in (b)(6) reported that on (b)(6) 2022, the nasal prong of an opt944 optiflow + adult nasal cannula was found to be folded over during use on a covid-19 patient and the patient desaturated.It was reported that the nasal prong was straightened, and the patient recovered.The healthcare facility further reported that at midnight on the same day, the pt101 airvo 2 humidifier alarmed during use on the patient, and was found to not be providing air flow.Staff checked the tubing, and air flow resumed.It was further reported that the patient became unresponsive, and a code blue was called, however the patient deceased.The healthcare facility further reported that the medical cause of death was cardiac arrest due to hypoxia.Further information has been requested regarding the reported event.
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A healthcare facility in canada reported that on february 15 2022, at approximately midnight, a pt101 airvo 2 humidifier generated a "check for blockages" alarm during use on a covid-19 patient and was found to not be providing air flow.While staff checked the tubing for kinks, air flow resumed.It was further reported that the patient desaturated to an approximate range of 70%-92% spo2 and became unresponsive.A code blue was called and resuscitation was initiated, however the patient deceased.The healthcare facility further reported that the medical cause of death was cardiac arrest due to hypoxia.The healthcare facility reported that hours prior to the event, the clinical staff attended to the patient due to an alarm and found the nasal prong of an opt944 optiflow + adult nasal cannula to be folded over on the same covid-19 patient and the patient desaturated.It was reported that the nasal prong was pulled out and straightened, allowing for the prescribed air flow to resume and the patient recovered with no further consequences.No further details or further clinical evaluation of the patient's condition were provided by the healthcare facility despite multiple efforts to obtain the information.
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(b)(4) (opt944 optiflow + adult nasal cannula) - k162533.(b)(4) (pt101 airvo 2 humidifier) - k131895.Product background: the pt101 airvo 2 humidifier (airvo 2) device is a humidifier with an integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces, one of which is the opt944 optiflow + adult nasal cannula (opt944).It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 system is not intended for life support and patient monitoring is required to be used at all times.Method: the subject airvo 2 and associated accessories; opt944 optiflow + adult nasal cannula (opt944 nasal cannula) and 900pt561 heated breathing tube and chamber kit (900pt561 hbt), were returned to fisher & paykel healthcare (f&p) for investigation.An investigation was carried out by f&p which was based on the information provided by the healthcare facility, our evaluation of the returned devices, and our knowledge of the product.Results: the healthcare facility reported that at approximately midnight, a pt101 airvo 2 humidifier generated a "check for blockages" alarm during use on a covid-19 patient and was found to not be providing air flow.While staff checked the 900pt561 tubing for kinks in light of the alarm, air flow resumed.The patient desaturated to 70%-92% spo2.A code blue was called and resuscitative efforts were initiated, however the patient deceased at 00:39.It was stated by the healthcare facility that the cause of death was cardiac arrest due to hypoxia.Earlier that evening, hours prior to the event, the clinical staff attended to the same patient due to an alarm and found the nasal prong of an opt944 nasal cannula was folded over and the patient desaturated.The nasal prong was pulled out and straightened, allowing for the prescribed air flow to resume and the patient fully recovered with no further consequences.It was also reported that the patient had been set up with an inhalation bag.No further details or further clinical evaluation of the patient's condition were provided despite multiple efforts to obtain this information.The airvo 2, opt944 nasal cannula and the 900pt561 hbt were returned to fisher & paykel healthcare for investigation and are no longer in use by the facility.Visual inspection of the returned airvo 2 revealed no sign of impact damage.A review of the device log confirmed that the "check for blockages" warning was logged on the day of the incident.The device was performance tested for an extended period of time.No error codes or warnings were observed, no faults were identified and the device performed as intended.The device was opened for further investigation and no internal faults were found.Visual inspection of the opt944 nasal cannula and 900pt561 hbt found no damage or potential causes for blockage.The devices were performance tested with the airvo 2 and it was found to be able to achieve its target flow of 60l/min without triggering any error codes or warnings.No faults or malfunctions were detected, and the devices performed as intended.The lot number for the opt944 was not provided, therefore the specific device history records (dhrs) were unable to be reviewed.However, these are reviewed for every manufactured lot (100%) as part of the final quality control checks at the completion of the assembly process, and the subject opt944 would have met all specifications at the time of release.The device history records (dhrs) were reviewed for the subject airvo 2.The device passed all the required quality control measures, confirming it was manufactured in accordance with specification.Additionally, no non-conformances were noted during the manufacturing process.Conclusion: we are unable to determine the cause of the reported event as there was no fault found with the returned devices.A "check for blockages" alarm, which includes both visual and audible alerts, is a result of the airvo 2 detecting a blockage in the system that would prevent the device from reaching the desired airflow.A blockage may occur anywhere in the gas path, from the device unit to the patient interface.While in alarm state the device attempts to continue to supply the required flow rate while continuously monitoring the restriction in the gas path.The alarm, both audio and visual, will continue until the blockage is cleared, and the required flow is once again achieved.The most likely cause of the reported event of the airvo 2 device providing no flow was a blockage in the gas path.A reduction or cessation in air flow may result from a restriction or obstruction anywhere in the gas path.As there was no blockage identified in the returned devices, the possible causes were likely temporary in nature.Temporary obstructions can include compression of the heated breathing tube or patient interface by patient movement.It is noted that during the inspection of the heated breathing tube by the nurse at the time of the event, the air flow resumed.It is therefore possible that during this inspection, whatever was obstructing the flow may have been moved.It was also reported the patient was set up with an inhalation bag.Inhalation (or reservoir) bags are typically used with non-rebreather masks which, when applied to a patient's face, compress the tubing of the opt944 nasal cannula.This compression increases the restriction in the airvo 2 system's gas path and reduces the gas flow to the patient.This may also result in a blockage alarm as reported in this incident.In reference to the initial desaturation hours earlier on the same covid-19 patient and based on our knowledge of the product, the nasal prong was likely to have been temporarily folded on the patient nares or face due to patient movement, such as adjusting and altering the cannula during therapy.This is likely to have led to a restriction of air flow to the patient.The user instructions describe the correct set-up to ensure secure fitting of the opt944, to withstand patient movement during therapy.During the manufacturing process of the opt944 and airvo 2 devices, quality control measures are in place to ensure the devices meet documented product requirements and specifications.These requirements and specifications encompass user needs, performance requirements, international product standards as well as quality system requirements.All opt944 nasal cannulas are subject to 100% in process checks.These include multiple checks of the following criteria: - no molding defects of components - correct assembly of all components - connector rotates 360 degrees freely - correct components are packed - no contamination is present - packaging seal integrity.All airvo 2 devices undergo the following specific controls to ensure each device delivers flow as per the device performance specifications and that the unit is free from any physical damage: - visual examination: each unit is visually inspected for external damage and to ensure all necessary components are assembled as per specification.- pressure flow testing: each unit is pressure tested and flow and oxygen measurements are verified to ensure there are no leaks in the airpath.- soak and reliability testing: each unit is connected to a hbt and water chamber, and then tested to ensure it performs as intended over extended operating conditions.- electrical safety testing: each unit is tested to ensure the unit meets electrical safety performance and requirements.These quality control measures are performed at the end of the final assembly process on 100% of the manufactured units.Any unit that fails any of these tests will be rejected.The airvo 2 humidifier user manual includes the following information and warnings: - "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases" - "the unit is not intended for life support." - "appropriate patient monitoring must be used at all times." - "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." in addition, the opt944 optiflow + adult nasal cannula user manual includes the following information and warnings: - "select appropriate size.Prongs must not create a seal in the nares.A clear gap must be visible around each prong." - "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." - "failure to use the set-up described above can compromise performance and affect patient safety".
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