(b)(6).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the autofill chamber as part of 900pt561 heated breathing tube and chamber kit is a component designed for use with the airvo 2 humidification series to provide nasal high flow (nhf) therapy.Air and oxygen are blown from the airvo 2 into the humidification chamber within which water is heated by a heater plate.The gases become humidified in the chamber and then pass into a heated breathing tube, then to the patient interface.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.
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Product background: the autofill chamber as part of 900pt501 heated breathing tube and chamber kit is a component designed for use with the airvo 2 humidification series to provide nasal high flow (nhf) therapy.Air and oxygen are blown from the airvo 2 into the humidification chamber within which water is heated by a heater plate.The gases become humidified in the chamber and then pass into a heated breathing tube, then to the patient interface.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint autofill chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: a visual inspection of the provided photograph revealed holes in the autofill chamber base, with rough edges, likely indicating that the base had eroded.The photograph provided by the healthcare facility also shows large amounts of white residue on the inside and outside of the autofill chamber.Conclusion: without the return of the complaint device, we are unable to confirm the cause of the reported event.However, based on previous complaints and our knowledge of the product, the chamber base can erode by accidently connecting sodium bicarbonate solution to the chamber instead of sterile water.Every autofill chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber.Any chamber that fails this test is rejected.The subject chamber would have met the required specification at the time of production.Our user instructions that accompany the 900pt501 heated breathing tube and chamber kit state the following: "use usp sterile/distilled water for inhalation or equivalent." "do not use the autofill chamber if it has been dropped or been allowed to run dry as this could lead to the chamber over-filling." "do not use the autofill chamber if the water level rises above the maximum water level line as this may lead to water entering the patient's airway." "for single patient use only.Reuse may result in transmission of infectious substances.Attempting to reprocess will result in degradation of materials and render the product defective." "avoid contact with chemicals, cleaning agents, or hand sanitizers.".
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A distributor reported in russia via a fisher and paykel healthcare (f&p) field representative that the autofill chamber, as part of the 900pt501 heated breathing tube and chamber kit, was found damaged at the chamber base.There were no reported patient consequences.
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