Draegerwerk—Disposable Breathing Circuits: ​May Not Connect Correctly to Anesthesia Machine and Short-Circuit, Potentially Causing Patient Harm

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In a December 2018 Important Safety Notice letter posted by MHRA, Draegerwerk states that the connections of the above breathing circuits and the anesthesia sets may be incorrectly connected, potentially causing the connections of the anesthesia machine and the y-piece to short-circuit. Draegerwerk also states that it received three reports of this problem occurring in which the patients did not receive the expected ventilation. In one of the three cases, the patient suffered irreversible harm. In another case, the patient experienced a temporary and reversible deterioration in condition. In the third case, no patients were affected, but it was reported that some breathing circuits had not been preassembled correctly. Breathing circuits are specially designed to allow the user to change the hose configuration so that the water trap is in the optimal position; therefore, this problem may also occur if the breathing circuit was correctly preassembled. If a short-circuited breathing circuit is not detected during the essential and compulsory pre-use check, it will not be possible to ventilate the patient. This can result in a deterioration to the patient's health and condition. Depending on the type of patient monitoring, this will be detected when the inspiratory O2 concentration falls or the O2 oxygen saturation level declines, and a corresponding alarm will be given. The precise cause of the above two cases with patient injury has not yet been determined. Independent from the possibility that an incorrectly preassembled breathing circuit was unpacked and installed, Draegerwerk states that these two cases indicate that the users did not verify the...