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

Catalog Number 10220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/14/2020

Event Type  Death  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation: per the customer, the replacement fluid used was fresh frozen plasma.A terumo bct service technician performed a service check on the device.The service technician replaced a defective replacement fluid sensor.An autotest and saline run were successfully performed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer called because they had noticed discolored plasma as soon as they connected the patient with thrombotic thrombocytopenia pupura (ttp) for a therapeutic plasma exchange procedure.Then, 20 minutes into the procedure, they started to see hemolysis in the remove bag and connector.The patient's doctor ordered rinseback and to discontinue the procedure.The patient was stable with normal vital signs and the doctor was going to consult with a hematologist regarding reason for the hemolysis.Upon follow up, the customer reported that the hemolysis was determined to be due to disease state.The customer stated that the patient had expired on (b)(6) 2020.Per the customer, cause of death was the patient's disease, determined by the doctor and the patient did not passed during or after the tpe procedure.No autopsy report is available.The customer declined to provide patient age, weight, and gender.Patient identifier is not available at this time.This report is being filed due to patient death, though at this time there is not an allegation that the device caused or contributed to the patient death.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.Analysis of run data file indicated the device operated as intended and is safe to use.The automated interface management(aim)system images were clean and clear and the lighting was in the appropriate range as well.Run summary: actual fluid balance: 107 ml (102%) procedure time: 27 min saline to patient: 87 ml ac to patient: 32 ml rinseback was completed total plasma removed: 686 ml replacement plasma used: 662 ml received alarm(s): x4 "cells were detected in the plasma line from the centrifuge" and x1 "confirming selection to disable rbc detector" the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Per internal medical review and analysis, the device did not cause or contribute to this incident.Root cause: based on the physician's statements, supported by the clinical findings, rdf analysis, the service performed on the device, the cause of the patient's death was due to the patient's medical condition.The plasma free hemoglobin contents in the patient's plasma triggered 'cells were detected in plasma line from centrifuge' alarms.Based on the physician's statements, the cause of hemolysis was related to the disease progression of the ttp.Based on the clinical and investigation findings, there is no evidence to suggest that malfunction or user error of the spectra optia device or optia disposables caused or contributed to the patient's death.Based on the physician's statements reported to the terumo bct customer support representative and investigation of this event, the cause of the patient's death was likely due to their underlying medical condition.

Event Description

Patient sex and weight were obtained from the run data file.

Manufacturer Narrative

This report is being filed to provide additional information in b.5.

Event Description

The customer declined to provide the patient identifier.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10635386
• MDR Text Key: 210006705
• Report Number: 1722028-2020-00457
• 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,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 76