It was reported that during surgical procedure anesthesia administration, the connector has been disconnecting on the anesthesia circuits.It was reported that the disconnection is occurring between the "wye piece" and the "90 degree elbow" resulting in frequent accidental disconnections of the circuit.The facility states, "this is resulting in an occupational hazard of increased anesthetic vapor exposure to providers as well as placing the patients at potential risk of hypoxia and hypoventilation." the reporter also stated that the disconnection causes a prolongation of the induction.No further adverse health outcomes have been reported.
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The customer reported that 21 devices contributed to 21 reported events (one device per event).The customer returned one device for evaluation.It could not be determined which occurrence the device was associated with; therefore, the evaluation of the device will be used for the medwatch.The following mfrs were submitted related to the evaluation: 3012307300-2016-00299, 3012307300-2016-00354, 3012307300-2016-00461, 3012307300-2016-00462, 3012307300-2016-00463, 3012307300-2016-00464, 3012307300-2016-00465, 3012307300-2016-00466, 3012307300-2016-00467, 3012307300-2016-00468, 3012307300-2016-00469, 3012307300-2016-00470, 3012307300-2016-00471, 3012307300-2016-00472, 3012307300-2016-00473, 3012307300-2016-00474, 3012307300-2016-00475, 3012307300-2016-00476, 3012307300-2016-00477, 3012307300-2016-00478, and 3012307300-2016-00479.One portex® pediatric disposable anesthesia breathing circuit (lot number 3205026) was returned for investigation.The device was received within its original opened package.The sample's elbow and wye were measured using a coordinate measuring machine.Each component's inner diameter and outer diameter measured within specifications.Next, a force test was performed by connecting the 90 degree elbow to a test fixture which pulls the circuit until a separation occurs.This test found the wye and 90 degree elbow to separate within the specified limits.Investigation was unable to confirm the reported issue and found that the device operated as intended.
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