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 Problems Anemia (1706); Reaction (2414)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: the study id is cts-5075.Investigation is in process.A follow-up report will be provided.

Event Description

During a terumo bct clinical trial from china, a patient undergoing a procedure on spectra optia device experienced high blood pressure and anemia.The patient was given a nifedipine tablet.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 and e.1.Investigation is in process.A follow-up report will be provided.

Event Description

Since this adverse event occurred during a clinical trial, only the subject id was provided.Patient age, gender, and weight are not available.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: 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.

Manufacturer Narrative

A disposable history search found no other reports of similar issues associated with this lot.Root cause: a definitive root cause for the high blood pressure and anemia could not be determined.Possible causes include but are not limited to: patient's medical condition - patient's sensitivity to the therapeutic procedure and/or clinical environment - collected product with high hematocrit.

Event Description

Since this adverse event occurred during a clinical trial, patient outcome is not available.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9330752
• MDR Text Key: 167341078
• Report Number: 1722028-2019-00343
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention