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

Model Number 61000

Device Problems Inadequate User Interface (2958); Data Problem (3196)

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

Event Date 04/09/2014

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.Patient information is not available at this time.Entered weight of patient: 170 (b)(6) protocol performed: therapeutic plasma exchange (tpe).

Manufacturer Narrative

This report is being filed to provide in 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 two additional issues related to thereported condition identified.These were reported in 1722028-2019-00206 (aug.2019) and1722028-2019-00207 (aug.2019) respectively.Correction: 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.Optia field action 24 will additionally address this issue by updating all optia devices in the field tosoftware version 11.3.This software version will allow the optia device to determine if enteredpatient height and weight combinations are feasible.This upgrade was completed for this deviceon october 14, 2016 and will no longer allow for height and weight data entry errors.Corrective action: an internal capa has been initiated to address incorrect patient dataentry.Root cause: user interface issue.

Event Description

The customer declined to provide patient information or further procedural details for thisevent.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8850969
• MDR Text Key: 165019863
• Report Number: 1722028-2019-00205
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (y/n): N
• PMA/PMN Number: BK130031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other