MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Human-Device Interface Problem (2949); Inadequate User Interface (2958); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

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.This issue was identified internally.There was no adverse event reported, therefore, patient identifier, age, and gender are not reasonably known.Patient weight was obtained from the run data files that were analyzed.Entered (b)(6).Protocol performed: therapeutic plasma exchange.

Manufacturer 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.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.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.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.Patient¿s gender was obtained from the run data file.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6077180
• MDR Text Key: 59557865
• Report Number: 1722028-2016-00593
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Other Device ID Number: 05020583610002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 83