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Investigation: the investigation has been conducted without a returned product and is therefore solely based on questions/answers and internal review of records as well as accumulated technical experience from the development of the product.Follow up questions to the initial reporter: 1.Was there an adhesive or tube in place when the user came to the hospital, or an open stoma? answer: yes - adhesive.2.If adhesive, who put it on the user? answer: caretaker at the nursing home 3.Is the user able to detach/attach the hmes himself? answer: yes, he takes the hme off when coughing 4.Is the user able to detach/attach and adhesives himself? answer: no, his caretakes help him with adhesive 5.If possible, please ask again how the hme came into the trachea.Answer: see answer on question 6 6.In which direction was the hme going into the stoma? answer: he was alone and do not remember the direction.He remember being coughing a lot and he got short of breath because of the exertion/effort.There might have been some mucus on the hme/fingers.Luckily he was able to call for help/pull the emergency alarm in the room.7.The incident - was the hme attached the whole time, or did the user try to put it in after he cough it out? answer: he tried to put it back on after coughing 8.When inspecting the hme, was it intact? answer: the provox life night hme was intact after being picked up with an optical pliers (foam and housing).9.Was the foam still inside the hme? answer: see question 8 10.When was the user laryngectomized? answer: january 2020 11.How long has the user been using the hme/adhesive/tubes? answer: hme and adhesive since operation january 2020 12.How long has the user been using the night hme product (not only this batch)? answer: night hme since january 7th 2021 (first shipment) 13.When was the user diagnosed dementia/alzheimer? answer: 8-10 years ago 14.How is the mental state of the user right now? answer: pretty good.His function is fine.He could help the caretaker to find the right box in his closet, when she was looking for the lot and ref number.He knows what has going on - it is more because of panic, he don't remember the situation.15.What adhesive where used? answer: provox life night adhesive ref 8261 lot 2010101 16.How is the user feeling today? answer: fine, i just talked to his son.The complaint report states that the hme was very slippery with mucus and that the hme must have been pushed or sucked into the trachea when the user tried to reattach the hme after a huge cough.Ifu in section 1.2 contraindications, the ifu states: the product shall not be used by patients with a decreased level of consciousness, patients with reduced mobility of the arms and/or hands, or patients who are unable to remove the device themselves.Manufacturing and quality inspection documents: lot 2012158 (provox night hme ref (b)(4)) were investigated and no remarks/deviations were found that could have an impact on the performance of the product.Lot 20.481.05 (night hme assembly ref (b)(4)) were investigated and no remarks/deviations were found that could have an impact on the performance of the product.Lot 2010101 (provox night life adhesive ref (b)(4)) were investigated and no remarks/deviations were found that could have an impact on the performance of the product.Lot 20.402.12 (ar2, weldable adapter lipsnap ref (b)(4)) were investigated and no remarks/deviations were found that could have an impact on the performance of the product.Previous complaint investigation: no previous investigations on similar incidents exists.Discussion: the user states that there might have been some mucus on the hme and the fingers.This makes the hme slippery to hold and control while attaching it.The ifu states that the product shall not be used by patients with a decreased level of consciousness.The user in this case have been diagnosed with dementia/alzheimer since 8-10 years.Verifications (tr-20-019) done to measure the force to push the hme through the adhesive when it is attached the correct way (requirement 1.3.1 in pf101-01 rs ed16) shows a result well above the lower tolerance limit (average 33.53n with a standard deviation of 0.646 and a minimum requirement of 5.6n).Bench tests with a lubricated hme (the hme was completely covered with silicone oil) to simulate a hme covered with mucus.The same setup were used as in tr-20-019.The test results with the lubricated hme shows no change in the results compared to a dry hme.If the hme has been inserted in an incorrect direction, the force to push the hme through the adaptor might be significantly lower.No changes on the material or design of the product have been made after the verifications that can be related to the hme getting pushed through the adaptor more easily.Manufacturers investigator conclusion: if the hme is attached in the correct way, it's very unlikely that it gets pushed through the adapter by accident.The forces measured in bench tests greatly exceeds the forces which may arise when attaching the hme.A more likely scenario is that the hme has been inserted in an incorrect direction.If the hme is inserted sideways, the force to push the hme through the adaptor is lower.A contributing factor to this might be that the user has a decreased level of consciousness (diagnosed with dementia).Since the product is new on the market, this eventual problem should be monitored closely.The investigation concludes that it is not likely that the incident was caused by a faulty product.
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An (b)(6) man ((b)(6)) was brought to the hospital due to respiratory problems after a very severe coughing fit.Fiberscope verifies a night hme occluding the right main bronchus.In ga the hme had been taken up with some damage to the mucous membran.Antibiotic medicine was given per and post operation.The man was back home after 12 hours.As the user recalls, the hme was very slippery with mucus.After a huge cough the user tried to reattach the hme, and it got pushed or sucked into the trachea.Description of the product: provox life hmes are single-use devices for pulmonary rehabilitation.They come in different levels of humidification, breathing resistance and filtration that makes them suitable for different situations.The different provox life hmes are: home: when taking it easy, go: when you are out and about, energy: when physically active, protect: when you need protection from bacteria, virus, dust and pollen, night: when sleeping.Intended use: provox life hmes are single use heat- and moisture exchangers for patients breathing through a tracheostoma.
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