(b)(4).Method: the complaint mr290hfv vented autofeed humidification chamber was received to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290hfv chamber confirmed that the chamber base is damaged and there is a hole in the base.The hospital further reported that veletri medication was used for 21 days.The returned complaint mr290hfv vented autofeed humidification chamber was found to be highly contaminated, thus was not further analysed due to safety reasons.Conclusion: we were unable to determine what may have caused the reported failure mode at this stage.However, it should be noted that veletri drug which contains sodium salt was used for 21 days.Sodium salt is highly corrosive to aluminium.The presence of this solution could cause degradation of the aluminium plate over time.Every mr290hfv 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 mr290hfv vented autofeed humidification chamber state the following: - "do not use beyond 7 days maximum duration of use." - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.".
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