A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.Device evaluation: one photo was provided by the customer which 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.Results: the photo shows a pouch label of part number and lot number.The reported failure mode, no disposable alarm, is not observer in the picture therefore the complaint cannot be confirmed.Functional testing: no product has been received to conduct a functional test.Mitigation: the following are the process controls for the failure mode reported.Bag loading operation ay bag folds from each side toward the center approximately 6.6 mm (1/4 inch) to 9.5 mm (3/8 inch) to assure the correct position of the ay bag.The pump tube is adjusted between ffp arch and hooks during assembly process following the visual aid av-0198 rev 100.Detection: the following detection mitigations are placed in the manufacturing process to detect pump alarms.Per pm-1011 rev 124 leak testing, install ffp 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.Per pm-1012 rev 104 cassette in process testing production performs an accuracy test following the pm-322 rev 106 accuracy test procedure; takes a sample of 3 parts at shift start-up, the beginning of every job; at least every 5 hours.Per qp-67-2265 rev 105 quality procedure for disposable, quality takes a sample of 15 units at an interval of 2 hours plus or minus 30 minutes, prior to placing product in bag, 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 analyzing the photo provided, the root cause cannot be determined.Action taken 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.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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