This issue was not confirmed as the device was not returned for investigation.The root cause of the reported issue cannot be determined.The renasys system provides blockage detection from the controlled leak path (the t-connector) to the canister.A possible root cause for the reported issue is a leak in the tubing, canister or overflow filter which would prevent the blockage alarm from occurring.At this time no corrective action is recommended.It is recommended that the device be returned for investigation to rule out a possible device malfunction.The renasys ez device has been replaced by the renasys ez plus, which has some new features and modifications.In addition, as a result of similar complaints, smith & nephew has issued (b)(4) to initiate renasys product labeling updates.These labeling updates will provide enhanced information on the functionality of the alarms as they relate to the design of the device, and scenarios that can occur in clinical settings which may impact alarm functionality.
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