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

Catalog Number 000000000000010220

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

Patient Problems Bradycardia (1751); Death (1802)

Event Date 04/05/2014

Event Type  Death  

Event Description

The customer reported that a therapeutic plasma exchange (tpe) procedure was being performed on a patient in icu.Approximately 30 minutes into the procedure, the patient's heart rate dropped and a code was called by the icu staff.Acls and cpr were given to the patient.Rinseback was performed during the code.They were able to get a heart rate and proceeded to re-start the procedure, but the patient's heart rate dropped again soon after.The patient expired on (b)(6) 2014.The customer declined to provide patient's identifier.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to patient death, although there is no alleged device involvement or malfunction.

Manufacturer Narrative

Investigation: per the customer, the attending medical director had ordered platelets prior to the event to be given to patient.The patient developed a reaction to the platelets, so a tpe was ordered.The physician didn't want to give any blood prior to the tpe due to the patient's reaction to the platelets.The operator originally contacted terumo bct's clinical support line due to "cells detected in plasma line" alarm.The operator stated that she couldn't see an interface, and that she didn't see any plasma in the remove bag.She also stated that the replacement fluid wasn't dripping.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Attempts made to gather the patient's discharge summary were unsuccessful.The run data file (rdf) was analyzed for this event.The run data file analysis shows that the multiple "cells detected in the plasma line alarms" were likely caused by hemolysis.The hemolysis is likely due to the patient's condition of thrombotic thrombocytopenic purpura (ttp).A service call was placed to have the optia equipment involved in the event checked out at the customer site.A full checkout and a saline simulated run were performed.No issues or abnormal conditions were noted.Root cause: based on the patient information, the customer's description of the procedure,and the run data file analysis, the cause of death was the patient's disease state.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately to the mdr form.This supplement is being filed to modify information to align with the reported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3786810
• MDR Text Key: 4430371
• Report Number: 1722028-2014-00145
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131744
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Catalogue Number: 000000000000010220
• Device Lot Number: 11V3212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00031 YR
• Patient Weight: 47