H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer confirmed that the affected product caused the patient to inhale breaths from which c02 hadn't been removed.Also, fic02 was elevated to 9.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
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Device evaluation: g3, g6, h2, h3, h6 and h10 production records showed no deviations from the specification of the device during manufacture.All units packed passed a 100% leak test and visual inspection.A review of the batch documentation under lot number l01a-01526 was within specifications on usp co2 absorption.The returned samples were received in such poor condition; the packaging did not state they were fragile units, and all canisters had cracks due to damage during transportation until our facilities, exposing the soda lime to the elements, making them unsuitable to be subjected to tests and reflecting accurate results.We conducted a thorough evaluation of retained samples (devices and material) from the same batch retained by the manufacturer.These units were subjected to visual inspections, leak tests, and usp co2 absorption assessments, and all retained samples successfully met the required standards.Possible causes of the lack of absorption could be issues linked to: a) the flow rate of gas through the absorber may be too high or too low, affecting the absorption efficiency; b) the equipment used to measure co2 levels may require calibration or maintenance; or c) human error, such as incorrect settings or adjustments during use.
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