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 04/11/2016 |
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).Protocol performed: secondary plasma device (spd).
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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 enteredincorrectly, resulting in an unreasonable body mass index.Such a data entry error can lead to, insome instances, an over infusion of ac or a hypervolemic or hypovolemic condition if the error isnot identified and corrected by the operator.There has been no indication that such an eventdid occur with this procedure.This issue was identified during an internal evaluation of available run data files.No on-siteservice was performed.One year of service history was reviewed for this device with no issues related to the reportedcondition identified.Terumo bct has followed up with this customer to provide feedback on the reported condition.Root cause: the root cause has been determined to be a user interface issue.Optia field action 24 has been initiated to correct this issue by releasing a safetynotification to all optia users to express the importance of entering the correct patient data andfollowing the operator's manual and on-screen prompts.An internal capa has been initiated to address incorrect patient dataentry.The field action referenced above will address this issue by updating all optia devices in thefield to software version 11.3.This software version will allow the optia device to determine ifentered patient height and weight combinations are feasible.
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Event Description
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Due to (b)(6) personal data protection laws, the patient information is not available from the customer.Patient¿s gender and weight were obtained from the run data file (rdf).
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Search Alerts/Recalls
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