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

Catalog Number 12220

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

Patient Problem Sepsis (2067)

Event Date 12/21/2018

Event Type  Death  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: methods: a retrospective observational study was performed at the atertiary care center for liver diseases in north india from january 2012 to september 2015.All patients awaiting liver transplantation who underwent therapeutic plasma exchange during the study period were included.Patients who developed sepsis or multiorgan dys-function prior to the tpe and patients with the category iv indication, as per the 2016 asfa guidelines, were excluded from the study.All tpe procedures were performed by a trans-fusion medicine specialist, along with the critical care team, using the spectra optia apheresis system at the liver intensive care unit.In each procedure, approximately one plasma volume was exchanged, as per the clinical indication and the requisition from the treating clinician.The tpe procedures were performed everyday, using fresh frozen plasma (ffp) as the main replacement fluid.The acid-citrate-dextrose (acd) anticoagulant was used in a ratio of 1:14 with whole blood throughout the procedure.Reference: maheshwari, a., bajpai, m., patidar, g.K.Effects of therapeutic plasma exchange on liver function test and coagulation parameters in acute liver failure patients.Hematology, transfusion and cell therapy.2020.42:125 investigation is in process.A follow-up report will be provided.

Event Description

According to the article, "effects of therapeutic plasma exchange on liver function test and coagulation parameters in acute liver failure patients", a retrospective study was done on critically ill liver disease patients who under-went tpe from january 2012 to september 2015.The data were collected for the analyses of coagulation parameters, liver function tests, renal function tests, model for end-stage liver disease (meld) scores, mortality, and hospital stay.Adverse events: a total of 14 patients died during their hospital stay and the major cause of death was septic shock, associated with multi-organ failure.The durationof the hospital stay was longer for patients who succumbed,as compared to that of those who survived, but this was not significant (p = 0.125) exact patient details were not provided in the article, therefore this report is being provided as a summary of the events.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: pr internal medical review and analysis, the optia device(s) did not cause or contribute to the reported deaths.Root cause: the authors stated that a total of 14 patients died during their hospital stay and the major cause of death was septic shock, associated with multi-organ failure.

Event Description

Since this was a retrospective study on critically ill liver disease patients who under-went tpe from (b)(6) 2012 to (b)(6) 2015, the disposable sets were not available for return.A request for specific patient information is not feasible.During the study period, a total of 45 patients with critical liver disease underwent therapeutic plasma exchange.The mean age of the patients was 37.75 years.In the study, (b)(4) of the patients were males, and (b)(4) females.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: a total of (b)(4) died during their hospital stay and per the article, the major cause of death was septic shock, associated with multi-organ failure.There is no evidence to indicate that the optia device caused or contributed to the sepsis which led to the patient death.Dhr details: since this was a retrospective study on critically ill liver disease patients who under-went tpe from (b)(6) 2012 to (b)(6) 2015, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11148086
• MDR Text Key: 226062294
• Report Number: 1722028-2021-00012
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K183081
• Number of Events Reported: 14
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 04/28/2022; 05/16/2022
• Supplement Dates FDA Received: 05/09/2022; 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other