It was reported by the affiliate in that during an anterior cruciate ligament reconstruction surgery on (b)(6) 2021, it was observed that when the fill button on the fms vue pump was pressed, its fill chamber would fill up and would continue to fill which caused it to backfill itself.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the device.Failure - fms vue pcba; failure - electrovanne assy (97-2-50120).The repair of the device was however declined, and it is being placed into long term hold.The faulty parts was identified as the root cause for the device failure during the service evaluation.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
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