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The required reporting date for this mdr was the 12th may 2021, due to numerous issues aerogen ltd experienced with the test submission account in which were notified to fda (reference ticket (b)(4)) aerogen ltd were unable to submit through medwatch on that date.Aerogen ltd received access to the production account on the 14th may 2021, and is now filing the mdr report.According to fda 21 cfr 803.3 (o), mdr reportable event (or reportable event) means: an event that manufacturers or reporters become aware of that reasonably suggests that one of their marketed devices: may have caused or contributed to a death or serious injury, or has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Based on the fact that the event 'may have caused or contributed to a death or serious injury' with no patient impact from this event, aerogen determined that the occurred event is an mdr reportable adverse event.Aerogen have taken the appropriate measures to review and investigate the complaint received, including the following: aerogen received back the device (20th april 2021) and completed the returned product investigation.On receipt of the device visual inspection was completed, there does not appear to be any damage or deterioration to the solo plug or tethered loop.Further investigation included nebuliser flow rate test, nebuliser electrical characteristic test and dimensional check of the plug and nebuliser cap.All tests completed passed, results provided.No functional fault found with the device.There was no dame or deterioration of the solo plug identified during visual inspection.The flow rate and electrical characterisation were found to be within specification.The dimensions of the solo plug and solo cap were examined and found to be within specification.No issues were identified with the t-piece.Risk assessment has been completed to summarize the risk analysis conducted per aerogen's risk management procedures and (b)(4).This assessment included detailed analysis of potential root cause, review of solo plug related instructions and warnings in the directions for use (dfu), risk mitigation design features of the solo plug, complaints review, severity of risk and risk analysis of current risk documents.The risk assessment (solo ii-0966) is provided as appendix 2.Clinical assessment has been completed for review of the event and clinical determination of potential to attribute to serious incident.The assessment included review of potential medical interventions that may be required and potential medical implications to the patient.This clinical assessment (solo ii-0968) is provided as appendix 3.In conclusion, as outlined within the risk assessment (solo ii-0966), from the manufacturer's investigations conducted to date, as outlined above, choking hazards are included in the current risk analysis for aerogen solo, documented in the solo shuma and are deemed severity "critical" per aerogen's risk management procedures.The probabilities for these hazards are the same as the incident under review and have the same mitigated risk values (iii).Additionally from clinical review, as outlined within the clinical assessment (solo ii-0968), this incident occurred in a (b)(6) patient with respiratory distress severe enough to require hfnc oxygen therapy and intermittent nebulisation therapy.Such patients are more usually managed in intensive care units with close monitoring rather than in a patient cubicle on a general paediatric ward.At (b)(6) it is doubtful that the infant would have the motor skills and power to remove the solo cap and tether from the solo unit unless perhaps the cap had been left open after the medication had been placed in the solo medication cup, outside of instructions as per the dfu.However, the child managed to acquire the accessory, he must have been unsupervised when he placed it in his mouth and the incident was only discovered when a nurse noticed the child chewing and removed the object.There are other hfnc nebulisation setups such as the fischer & paykel system where the solo would be on the dry side of the humidifier some 4 to 6 feet away and not within reach of the child.This incident in (b)(6) hospital ((b)(6)) has been categorized by aerogen as a near-miss incident that could have resulted in aspiration or ingestion of a foreign body with the above potential outcomes, requirements for medical intervention and potential complications.There was no patient injury in this case, no medical intervention was required and there was no impact to the patient.This near miss incident is one of only two such events in 8 years (previous was 2017) and since 2017 to 2020, inclusive (b)(4) solo nebulisers shipped.This equates to a probability of (b)(4) or (b)(4)% which is extremely rare.A number of different factors have come together to create the circumstances where this rare event could occur, however the risks of recurrence are extremely low, and no harm has come to the patient.Therefore, based on assessments completed to date there was no device malfunction found, and there are no further actions determined by aerogen at this time, and aerogen will continue to monitor complaints received, the occurrence rating and severity of the risk as per aerogen's quality management system.The mdr report is being submitted as combined initial and final 30 day report, the event investigations have been concluded and the complaint will be closed as per aerogen's quality management system.Should the aforementioned preposition change by the time the complaint is officially closed, the new and/or additional information will be provided to fda through a further mdr report.
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On 12th april 2021, aerogen were notified of on an incident related to the plug top of the aerogen solo nebulizer and a pediatric patient.The event involved a (b)(6) patient on the (b)(6) 2021.The patient was receiving high flow therapy connected to vapotherm adapter, the nebulizer kit was connected between the oxygen tubing and the nasal cannula, aerogen solo nebulizer and pro-x controller were utilized.The patient was in a general children's ward with the patient cared for in a cubicle.The healthcare provider indicated that the plastic/rubber cap attached to the consumable part, identified by aerogen as the nebulizer plug top, was found in the patient's mouth by a member of the healthcare nursing team.There was no harm to the child and no medical intervention was required.The healthcare provider was present during initial use of the device.The patient's mother and nurse were present at the time of incident.The device has been returned to the manufacturer.
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