A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative that a mr290v vented autofeed humidification chamber base plate had a pin-hole and water was leaking through the pin-hole.The hospital further reported that nebulised drug diluted in saline solution was administered, and patient secretion and condensation in the breathing circuit was returned to the mr290v vented autofeed humidification chamber.It was also reported that the mr290v chamber was used for approximately 12 days.There were no patient consequences.
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(b)(4).Method: the complaint device mr290v humidification chamber was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection confirmed that a hole was found on the base of the chamber.Additionally, a stain was found on the inside of the chamber dome and base.Further analysis of the subject mr290v chamber base confirmed the presence sodium chloride in the chamber dome and on the interior surface of the aluminium baseplate.Conclusion: based on the information provided by the customer and our investigation of the complaint device, the cause of the degradation is due the presence of sodium chloride solution in the mr290v chamber.Sodium salt is highly corrosive to aluminium.The presence of this solution could cause degradation of the aluminium plate over time.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.The subject chamber would have met the required specification prior to distribution.Our user instructions that accompany the mr290v vented autofeed humidification chamber states the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "use usp sterile water for inhalation or equivalent.".
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A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative that a mr290v vented autofeed humidification chamber base plate had a pin-hole and water was leaking through the pin-hole.The hospital further reported that nebulised drug diluted in saline solution was administered, and patient secretion and condensation in the breathing circuit was returned to the mr290v vented autofeed humidification chamber.It was also reported that the mr290v chamber was used for approximately 12 days.There were no patient consequences.
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