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 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: the study id is (b)(4).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 decreased potassium.Per the customer the patient was given potassium chloride 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.

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.

Manufacturer Narrative

This report is being filed to provide additional information in a.2, a.3, a.4, b.6, e.1, e.3, h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.A conclusive root cause for the decrease in potassium levels for this procedure could not be identified.The system operated as intended and the procedure was run within standard operating limits (i.E.Not in ¿caution status¿).Review of the aim images showed that the images were hazy possibly due to dirt or film on the lighting components.It is recommended to clean these components as explained in the spectra optia system operators manual to help optimize system performance.This is likely unrelated to the decrease in potassium levels but should be addressed.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.A disposable history search found three other reports of a similar issue associated with lot 1902083130 from the same clinical trial.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information e.1.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10.Root cause: a conclusive root cause for the decrease in potassium levels for this procedure could not be identified.Possible cuses for the alleged hypokalemia include but are not limited to ac management during the procedure, patient disease state and/or patient sensitivity to anticoagulant.

Event Description

Per the customer, the patient was reported as resolved/recovered.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9526032
• MDR Text Key: 188235616
• Report Number: 1722028-2019-00443
• 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,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: 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: 12/07/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/30/2020; 03/02/2020; 03/11/2020; 04/02/2020
• Supplement Dates FDA Received: 02/11/2020; 03/06/2020; 03/31/2020; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00072 YR
• Patient Weight: 55