| Model Number RT232 |
| Device Problem
Disconnection (1171)
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| Patient Problem
Low Oxygen Saturation (2477)
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| Event Date 07/16/2022 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complaint rt232 adult optiflow circuit kit with microcell technology is currently en-route to fisher & paykel (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.
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Event Description
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A healthcare facility in california reported via a fisher & paykel healthcare (f&p) field representative that the dryline of a rt232 adult optiflow circuit kit with microcell technology had disconnected during use.It was reported that the patient decompensated as a result of the disconnection.The nature of the decompensation has not been provided.No further patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Corrections: section d9 and h3: initially requested for the device to be returned to fisher & paykel healthcare (f&p), however, it was later confirmed that the complaint device was discarded by the hospital.Section h6: health impact code - updated to 4635 as the healthcare facility confirmed the patient had desaturated unexpectedly.As the complaint circuit was discarded, we requested the the lot numbers from all available lots in the hospital's stock.Retained samples from each lot was obtained from our manufacturing site and dimensionally tested.Taper measurements were taken from each retained sample, and were found to be within specification.The device history records (dhrs) for the lots the hospital had in stock were reviewed (lots: 2101922482, 2101949448, 2101807240, 2101421333, 2101638312, 2101647617, 2100997421).No nonconformances were noted on the dhrs and it is confirmed that those lots were manufactured according to specification and passed all the required control measures.We are currently awaiting samples from the hospital to be returned to new zealand for investigation.We will provide a follow-up report upon completion of our investigation.
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Event Description
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A healthcare facility in california reported on 20 july 2022, via a fisher & paykel healthcare (f&p) field representative, that the dryline of a rt232 adult optiflow circuit kit with microcell technology had disconnected during use.It was reported that the patient decompensated as a result of the disconnection.Additional information was then received on 17 august 2022, from the healthcare facility via a f&p field representative, reporting that on (b)(6) 2022, the patient was started on heated humidified high flow (hhhf) oxygen set up with the complaint rt232 adult optiflow circuit kit with microcell technology.The healthcare facility reported that the patient had a respiratory rate in the mid 20-30s.The days following (b)(6) 2022, it was reported that the patient was in atrial fibrillation.It was not noted how this occurred or if this was resolved.The patient's respiratory rate had increased into the 30s and at times into the 40s.On (b)(6) 2022, it was reported that the flow rate from the hhhf oxygen blender was increased to 30l/min at 80% oxygen during the day shift and increased further to 40l/min at 100% during the night shift.It was reported that the patient had desaturated to 90% spo2.In response, the flow rate was increased to 50l/min at 100%.The following day, (b)(6) 2022, it was reported that the dryline of the rt232 circuit had disconnected from the mr290 autofeed vented humidification chamber inlet port.The patient then desaturated to 63% spo2.The flow rate of the hhhf was increased to the maximum allowable flow, 60l/min at 100% oxygen.It was reported that three minutes after the desaturation, the disconnection location was identified by the medical staff.Soon after, the patient was found to be in pulseless electrical activity (pea) cardiac arrest.Approximately 10 minutes later, the patient had deceased.It was noted that the patient had a do not resuscitate (dnr) order.
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Event Description
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A healthcare facility in california reported on 20 july 2022, via a fisher & paykel healthcare (f&p) field representative, that the dryline of a rt232 adult optiflow circuit kit with microcell technology had disconnected during use.It was reported that the patient decompensated as a result of the disconnection.Additional information was then received on 17 august 2022, from the healthcare facility via a f&p field representative, reporting that on (b)(6) 2022, the patient was started on heated humidified high flow (hhhf) oxygen set up with the complaint rt232 adult optiflow circuit kit with microcell technology.The healthcare facility reported that the patient had a respiratory rate in the mid 20-30s.The days following (b)(6) 2022, it was reported that the patient was in atrial fibrillation.It was not noted how this occurred or if this was resolved.The patient's respiratory rate had increased into the 30s and at times into the 40s.On (b)(6) 2022, it was reported that the flow rate from the hhhf oxygen blender was increased to 30l/min at 80% oxygen during the day shift and increased further to 40l/min at 100% during the night shift.It was reported that the patient had desaturated to 90% spo2.In response, the flow rate was increased to 50l/min at 100%.The following day, (b)(6) 2022, it was reported that the dryline of the rt232 circuit had disconnected from the mr290 autofeed vented humidification chamber inlet port.The patient then desaturated to 63% spo2.The flow rate of the hhhf was increased to the maximum allowable flow, 60l/min at 100% oxygen.It was reported that three minutes after the desaturation, the disconnection location was identified by the medical staff.Soon after, the patient was found to be in pulseless electrical activity (pea) cardiac arrest.Approximately 10 minutes later, the patient had deceased.It was noted that the patient had a do not resuscitate (dnr) order.
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Manufacturer Narrative
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(b)(4).Method: the complaint rt232 adult optiflow circuit kit 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 rt232 adult optiflow circuit kit had disconnected from the humidification chamber during use.It was reported that three minutes after the desaturation, the disconnection location was identified by the medical staff.Soon after, the patient was found to be in pulseless electrical activity (pea) cardiac arrest.Approximately 10 minutes later, the patient had deceased.It was noted that the patient had a do not resuscitate (dnr) order.As the complaint circuit was discarded, we requested the the lot numbers from all available lots in the hospital's stock.Retained samples from each lot was obtained from our manufacturing site and dimensionally tested.Taper measurements were taken from each retained sample, and were found to be within specification.The device history records (dhrs) for the lots the hospital had in stock were reviewed (lots: 2101922482, 2101949448, 2101807240, 2101421333, 2101638312, 2101647617, 2100997421).No nonconformances were noted on the dhrs and it is confirmed that these lots were manufactured according to specification and passed all the required control measures.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 rt232 adult optiflow circuit kit.Even with these specific set of abnormal conditions, a dryline disconnection was not able to be achieved consistently.The rt232 adult optiflow circuit kit 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 rt232 adult optiflow circuit kits 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 rt232 adult optiflow circuit kit 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.".
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