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.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.
|
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, age, and gender are not available at this time.Patient's weight was obtained from the run data file (rdf).Entered weight of patient: (b)(6), entered height of patient: (b)(6), calculated bmi: (b)(6), actual weight of patient: (b)(6), actual height of patient: (b)(6), actual bmi: (b)(6).Protocol performed: the rapeutic plasma exchange (tpe).
|