An internal investigation was performed of events in which an operator may have incorrectly entered patient data, creating an unreasonable body mass index (bmi).This event was identified during the internal investigation, not reported by the customer, therefore patient outcome is not available.Entered weight of patient: (b)(6) entered height of patient: (b)(6), calculated bmi: (b)(6), protocol performed: white blood cell collection.
|
This report is being filed to provide additional information in sex, weight, describe event or problem, evaluation codes, if remedial action initiated and additional mfr narrative.Investigation: the run data file (rdf) was reviewed for this run as part of an internal study.It was identified in the rdf that the patient weight and height may have been entered incorrectly, resulting in an unreasonable body mass index.Such a data entry error can lead to, in some instances, an over infusion of ac or a hypervolemic or hypovolemic condition if the error is not identified and corrected by the operator.There has been no indication that such an event did occur with this procedure.This issue was identified during an internal evaluation of available run data files.No on-site service was performed.One year of service history was reviewed for this device with no issues related to the reported condition identified.This device has been updated to v11.3 to no longer allow for height and weight data entry errors.Root cause: the root cause has been determined to be a user interface issue.Correction: optia field action 24 has been initiated to correct this issue by releasing a safety notification to all optia users to express the importance of entering the correct patient data and following the operator's manual and on-screen prompts.Optia field action 24 will additionally address this issue by updating all optia devices in the field to software version 11.3.This software version will allow the optia device to determine if entered patient height and weight combinations are feasible.This device this has been updated to v11.3 in september of 2016 and will no longer allow for height and weight data entry errors.Corrective action: an internal capa has been initiated to address incorrect patient data entry.
|