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

Catalog Number 12220

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

Patient Problem Cardiac Arrest (1762)

Event Date 11/04/2020

Event Type  Death  

Manufacturer Narrative

Investigation: the machine was checked out by a terumo bct technician.Functional verification performed and auto test performed successfully.The machine was returned to service.The run data file was analyzed for this event.Signal from the rdf showed no unusual alarms or abnormal procedure behavior.Given this information, there were no signals in the dlog that would indicate the machine did not operate as intended and the system was operating within the safety limits programmed in the machine.A disposable history search concluded there were no similar occurrences reported on this lot worldwide.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that 78 minutes into a therapeutic plasma exchange (tpe) procedure, the patient had a seizure and cardiac arrest.The code team was not able to resuscitate him.The patient had been confused prior to the procedure and became restless right before the seizure.The physician confirmed that the seizures and cardiac arrest were related to the patient's disease state.Upon follow--up with the customer, it was reported that the patient expired and the cause of death was related to the patient disease state.The disposable set is not available for return because it was discarded by the customer.The patient went on to have a second tpe procedure in the evening of (b)(6) 2020 after consulting with the customer site medical director.On (b)(6) 2020 the family decided to discontinue tpe procedures after receiving pts mri results.The customer declined to provide further procedural details due to hippa laws.This report is being filed due to patient death, though at this time there is no allegation that the device caused or contributed to the patient death.

Manufacturer Narrative

This report is being filed, to provide additional information in h.6 and h.10.Investigation: per the customer, no autopsy was performed.A review of the device history record (dhr) for this unit showed no irregularities, during manufacturing that were relevant to this issue.Per terumo bct's medical review, the device did not cause or contribute to the reported death.Root cause: based on the information from the clinical and investigational findings, the cause of the patient's death was, due to the pre-existing disease condition.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10898062
• MDR Text Key: 218165415
• Report Number: 1722028-2020-00524
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 12220
• Device Lot Number: 2008103230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00057 YR
• Patient Weight: 120