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

Catalog Number 10220

Device Problems Coagulation in Device or Device Ingredient (1096); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Insufficient Information (4580)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry date are not available at this time.Investigation: per the customer, the fluids hanging were normal saline and acd-a and the solutions were correctly attached.No clotting was seen in the channel or channel lines.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that they had a sickle cell patient with hemolysis during a single needle red blood cell exchange procedure.The customer reported a red cells detected in plasma line alarm and pinkish plasma approximately 15 minutes into the procedure.Hemolysis testing was performed and the transfusion reaction work up was negative for hemolysis on dat.The customer reported that the rbcs did not separate when the product/tubing was spun or rested.Patient outcome is not available at this time.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 in h.6, and h.10 and corrected infromation in e.3.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.- an unidentified manufacturing defect in the disposable set.- inaccurate data entry.

Event Description

The customer did not respond to multiple attempts to obtain further event information.Full patient id: (b)(4).

Manufacturer Narrative

This report is being filed to provide additional information in b.6, e.3, h.6 and h.10.Investigation: 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.The run data file was analyzed for this event.The files show that the device operated as intended and is safe for continued use.The pumps operated within the normal limits and there were no abnormalities in the pressure or level sensor readings.The aim images were clear, and the lighting was within specification.Signals in the run data files do not indicate a conclusive cause for the reported possible hemolysis.The only sensor that may be able to detect hemolysis is the red blood cell detector (rbc detector).The "cells were detected in plasma line from centrifuge" alarm is generated when the color of the fluid flowing through the plasma line changes for the normal clear plasma color.It cannot be determined if that color change is caused by hemolysis or actual red blood cells flowing through the plasma line.For hemolysis to be confirmed, the operators would have to visually see the discolored plasma and have it tested.The "cells were detected in plasma line from centrifuge" alarm can be indications of hemolysis.However this alarm can also be caused by an incorrect patient hematocrit.If the hematocrit entered is too low, the interface will be too high and can trigger either of these alarms.To run efficiently, the system needs the most accurate patient data available and to operate at a steady state.Entering the most accurate available patient data as early as possible into the run and addressing alarms with appropriate troubleshooting will help the system reach a steady state, decrease procedure times, and run efficiently.Though not related to the reported possible hemolysis, every procedure should be observed for platelet clumping in the connector and the collect port since it is difficult to predict the likelihood for platelet clumping to occur based on patient counts alone.A platelet clump tends to look like a dark clump, which may be light on either side, traveling through the collect port in the connector.This may be observed in the image on the collection status screen, or by looking though the view port.It is best to eliminate the clump and stop the clotting cascade as quickly as possible by decreasing the inlet:ac ratio to 8:1 until the clump disappears.If there is not a proper amount of ac in the system or clumping is already present, clots may form in the product bag.Analysis of the aim images from the procedure on october 1st showed clumping in the channel.At the time of the first appearance of clumping, the inlet:ac ratio was set to 13:1.Even though clumping was present in the collect port, the operator did not change the inlet:ac ratio.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET, EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10976563
• MDR Text Key: 250369284
• Report Number: 1722028-2020-00539
• 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,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 03/02/2021; 03/15/2021
• Supplement Dates FDA Received: 03/08/2021; 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Weight: 86