Model Number 61000 |
Device Problems
Use of Device Problem (1670); Inadequate User Interface (2958); Patient Data Problem (3197)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is in process.A follow-up report will be provided.
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Event Description
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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 information is not available at this time.Entered weight of patient: (b)(6), entered height of patient: (b)(6), calculated bmi: (b)(6), protocol performed: therapeutic plasma exchange (tpe).
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Manufacturer Narrative
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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 four similar reports of an incorrect data entry error with incident dates of (b)(6) 2016 (reported on mdr 1722028-2017-00120), (b)(6) 2016 (reported on mdr 1722028-2017-00115 and 1722028-2017-00119) and (b)(6) 2017 (reported on mdr 1722028-2017-00116).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.Terumo bct has provided feedback to the customer regarding the height/weight data entry error.
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Event Description
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The customer declined to provide procedural details, patient information, and patient outcome since no adverse events occurred.Patient¿s gender and weight were obtained from the run data file (rdf).
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Search Alerts/Recalls
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