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

Catalog Number 10316

Device Problems Low Test Results (2458); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 08/23/2019

Event Type  Injury  

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.The study id is (b)(4).Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a white blood cell depletion (wbcd) clinical trial on a spectra optia device, the patient had a lower platelet count.Per the customer the patient was given a drug combination treatment of carbazochrome and sodium sulfonate sodium chloride injection and the procedure was completed.Patient age, sex and weight are not available.Since this adverse event occurred during a clinical trial, only the subject id was provided.Per the customer the patient was reported as recovered.The disposable set is not available for return because it was discarded by the customer this product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the optia operator's manual includes the following warning for collection and depletion procedures: platelets are collected with target cells during continuous mononuclear cell collection (cmnc) procedures, granulocyte (pmn) collection procedures, and white blood cell depletion (wbcd) procedures.If the initial platelet count is low and the patient is not properly managed, excessive platelet depletion can occur.The clinical trial team determined the adverse event was not related to device deficiency.Investigation is in process.A follow-up report will be provided.

Event Description

Patient age is not available since this adverse event occurred during a clinical trial, only the subject id was provided.Patient gender and weight was obtained from the rdf.

Manufacturer Narrative

This report is being filed to provide additional information in a.3, a.4, b.5, b.6 and h.10 and corrected information in b.3.Investigation: the run data file (rdf) was analyzed for this event.The rdf was reviewed for common signals related to platelet loss such as aggregation in the connector, changes to the collect pump flow rate, changes to the packing factor, and use of a high collection preference (cp).The operator(s) made no changes to the default packing factor or collect pump flow rate during these runs.The cp for the procedure varied from 60-70 for the majority of the procedure.These is not considered an unusually high cp for wbcd procedures.Aggregation in the connector may contribute to platelet loss because those activated platelets may end up trapped in the connector.Additionally, clumping in the connector can be an indicator of clumping in the reservoir, which can also lead to residual platelets in the disposable set at the conclusion of the procedure.If clumping is identified, it is recommended to decrease the ratio to 8 and leave it there until the clumping has resolved.No obvious aggregation was present during the procedure, nor were there any alarms (i.E.Low-level reservoir sensor alarms) to indicate excessive clumping in the reservoir during any of the procedures.The cp is the main value used to optimize the collection.The system defaults to a cp of 75 for wbcd but it can and should be adjusted and can be set anywhere between 10 and 90.This should be changed during the run to meet the unique conditions of each patient and the desired outcome for the product.Typically, if the patient has high wbc and platelet counts a lower collection preference needs to be used.If the patient has low counts, a higher collection preference should be used.Patient disease state and blood physiology can also influence what collection preference needs to be used.The investigation is still in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10, and corrected information in e.1 and e.3.Investigation: a disposable history search found no other reports of similar issues associated with this lot.Root cause: a conclusive root cause for the platelet loss reported for this procedure could not be identified.Possible root causes include but are not limited to: procedure being run with an incorrect ac ratio resulting in platelet activation, leading to platelet depletion.Procedure being run with a low collect hematocrit, leading to platelet depletion.Procedure being run with a high collect flow rate, leading to platelet depletion.Patient's underlying disease state.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9483523
• MDR Text Key: 177012454
• Report Number: 1722028-2019-00420
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/17/2019

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 Expiration Date: 02/01/2021
• Device Catalogue Number: 10316
• Device Lot Number: 1902083130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/15/2020; 02/05/2020; 03/04/2020
• Supplement Dates FDA Received: 01/31/2020; 02/25/2020; 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 87