A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Evaluation: one) video was attached to the complaint created; this video was provided by the customer.The video was used to conduct the device analysis since the physical unit, by the time this investigation is being documented, has not been received in the tijuana site.The disposable was observed to be empty with the line not attached to the air detector and the distal end luer connector attached to an extension line; no damage or dysfunctional conditions are observed.In the video an alarm beep is heard, and the pump displays the message (air detector off).The reported failure mode, causes pump to alarm, is confirmed.Functional testing: no product has been received to conduct a functional test.Results: if the device arrives, smiths medical will reopen this complaint to include in the investigation the physical sample returned.Mitigation below are the controls during manufacturing process for the failure mode.Loading operation these are the current mitigations implemented in the process to prevent delivery issues: leak testing, install clip and luer capping production performs a 100% in process inspection, to verify for occlusions, kinked tubing, components damaged, verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.Procedure production performs an accuracy test 15 units at an interval of two hours plus or minus 30 minutes, prior to placing product in bag, in order to verify for occlusions, kinked tubing and verify that the bag is properly placed and verifies that the height of the arch of the pump tube is within specification.After reviewing the mitigations that are performed during the manufacturing process to detect pump alarms, and review of the video provide, the root cause cannot be determined.No corrective actions are required because the mitigations on place were revised and are executing as is determined by procedure.This failure will continue to be monitored to determine if new actions need to be taken.
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