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.Patient identifier and age are not available at this time.(b)(6).
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This report is being filed to provide additional information in pt identifier, sex, 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 and there were 4 similar reports of incorrect data entry errors with incident dates of (b)(6) 2016, and two in (b)(6) 2016 (reported on mdrs 1722028-2016-00649, 1722028-2016-00642, 1722028-2016-00650, and 1722028-2016-00645).During customer follow-up, the customer stated that a nurse at the customer's site was entering the height and weight incorrectly.Terumo bct has provided feedback to the customer regarding the height/weight data entry error.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.Corrective action: an internal capa has been initiated to address incorrect patient data entry.The field action referenced above will 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.The optia device at the customer's site was updated to the new software version 11.3.
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