MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 12220

Device Problems Material Discolored (1170); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals in the rdf indicate that the spectra optia system operated as intended.A cause for the discolored plasma is not known.The ¿cells were detected in plasma line from centrifuge¿ alarms that occurred during this run were likely a result of the falsely low entered replacement fluid hct (65% entered, 76%measured).Near the end of the procedure, the operator made changes to the patient¿s entered hct and the targeted patient end hct that resulted in a ¿current run targets could not be attained with value entered.System paused.¿ alarm.This alarm was triggered because the operator made a change that resulted in a mathematically unattainable procedure target.In this case, the system did not have valid targets, so the run stopped until valid targets were entered.A terumo bct service technician checked out the machine at the customer site.A full auto-test and saline run on this device on may 16, 2019 and found it to be in working order.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported during a red blood cell exchange (rbcx) procedure using a spectra optia device they saw discolored plasma and received a "cells were detected in plasma line for centrifuge" alarm on a patient with sickle cell disease.They suspected hemolysis was first noticed by the operator 1 hour and 45 minutes into the procedure.The operator reported clear separation of the cells in the connector.The plasma was a pinkish color in the lines in the cassette going to the reservoir.The operator verified saline and ac bags were connected to the appropriate lines.The physician decided to end the treatment as the cause of the discolored plasma could not be determined.Per the customer, after the procedure, the replacement fluid unit was spun down and the hematocrit (hct) was determined to be 76% (the replacement fluid hct was entered as 65%).The customer stated that they also drew samples from the channel and the cartridge that were spun and the customer reported that the doctor indicated there is frank hemolysis.The patient was give a transfusion workup, the results were negative.The patient is reported as stable and was discharged to go home.The customer declined to provide the donor identifier (id).The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in investigation: the customer sent 4 pictures taken during the procedure.Picture 1 confirmedpink plasma in the plasma line and recirculation line.Pictures 2 and 3 confirmed pink plasma in theconnector.Picture 4 confirmed the alarm 'cells were detected in the plasma line from thecentrifuge'.Root cause: a definitive root cause for the discolored plasma could not be determined.Possiblecauses include, but are not limited to:- the patient's underlying disease state.- an occlusion in the disposable set.- an unidentified manufacturing defect in the disposable set.- use of viscous replacement fluid.Based on the clinical findings and the run data analysis, the cause of the alarm was an incorrecthct value entered for the transfused rbcs.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8679249
• MDR Text Key: 148444597
• Report Number: 1722028-2019-00136
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 12220
• Device Lot Number: 1904033430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00015 YR
• Patient Weight: 51