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

Catalog Number 10220

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 06/06/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: lot number and expiry information are not available at this time.The customer stated that the plasma was not pink throughout the procedure, only toward the end.They were using fresh frozen plasma (ffp) as the replacement fluid.The icu staff had also started a red cell transfusion a few minutes prior to the plasma changing color.Terumo bct clinical specialist explained to the customer that potential causes of the pink plasma could be patient related, ffp being used as replacement fluid, or the red cell transfusion that was started.The customer understood the information discussed.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported receiving a "cells were detected in plasma line from centrifuge" alarm near the end of a therapeutic plasma exchange (tpe) procedure on a patient with suspected thrombotic thrombocytopenia purpura (ttp).Per the customer, the color in the plasma line was pink tinged.The physician was consulted, and they decided to end the procedure.The patient was in stable condition and hemolysis testing was not done.The customer declined to provide patient identifier.Patient age is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the potential hemolysis was observed in the plasma line as it exits the centrifuge towards the end of the procedure.It was not seen in other parts of the set.The physician did not confirm that the hemolysis was due to disease state.No hemolysis testing was performed.It is not known if the rbcs separate when the product/tubing is spun or rested.There were no clots observed in the channel or channel lines.No custom prime was performed.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: a definitive root cause for the discolored plasma could not be determined.Possible causes include but are not limited to: - the patient's underlying disease state.- hemolysis in the rbc unit that was transfused to the patient.- increase in the patient's hematocrit after rbc transfusion causing the interface to shift higher resulting in rbcs spilling over into the plasma line.

Event Description

Per the customer there was no medical intervention required and the current patient status was stable.The customer declined to provide the patient age.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10209068
• MDR Text Key: 200619444
• Report Number: 1722028-2020-00314
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 90