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 No Patient Involvement (2645)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: the study id is (b)(4).A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process a follow up report will be provided.

Event Description

During a terumo bct clinical trial from (b)(6), a patient undergoing a procedure on a spectra optia device experienced a decreased platelet count.Per the customer the patient was given platelets.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.

Manufacturer Narrative

This report is being filed to provide additional information in b.5.Investigation is in process.A follow up report will be provided.

Event Description

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

Manufacturer Narrative

It has been determined that the event submitted on this report is a duplicate of the event submitted on report 1722028-2019-00362.No further information will be submitted for this report.Please see 1722028-2019-00362 for event information and investigation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9525997
• MDR Text Key: 188235505
• Report Number: 1722028-2019-00442
• 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: 02/11/2020; 03/05/2020
• Supplement Dates FDA Received: 02/11/2020; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention