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

Catalog Number 10316

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

Patient Problem Reaction (2414)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: the study id is (b)(6).Investigation is in process.A follow up report will be provided.

Event Description

During a (b)(6) clinical trial from (b)(6) a patient undergoing a procedure on a spectra optia device experienced a reduced platelet count.Per the customer, the patient was given carlo sulfonate powder injection.Per the clinical trial report, no measure was taken for the studied device and the procedure was successful.Patient age, gender, weight and outcome are not available at this time.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.

Event Description

Patient outcome is not available from the customer as this is a clinical trial.

Manufacturer Narrative

This report is being filed to provide additional information in a.2, a.3, a.4, b.5, b.6, e.1, e.3, and h.10.Investigation: a disposable history search found one other report of a similar issue associated with lot 1905233230 from the same clinical trial.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 67-75 for the majority of the procedure.This 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.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.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6, and h.10.Investigation: the device history record (dhr) was reviewed for this lot.There were no issues identified in the dhr that would have contributed to the patient reaction as experienced by the customer.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide patient age, gender, or weight.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9525867
• MDR Text Key: 174408255
• Report Number: 1722028-2019-00440
• 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
• Report Date: 12/27/2019

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: 05/01/2021
• Device Catalogue Number: 10316
• Device Lot Number: 1905233230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/30/2020; 03/04/2020
• Supplement Dates FDA Received: 02/11/2020; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00045 YR
• Patient Weight: 60