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 Reaction (2414); Insufficient Information (4580)

Event Date 10/25/2019

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 hypokalemia.Per the customer the patient was given a calcium gluconate 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 h6 and h10.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged hypokalaemia include, but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.

Event Description

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

Manufacturer Narrative

This report is being filed to provide additional information in b.5, e.1, e.2, h.6 and h.10.Investigations: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable history search found no other reports of similar issues associated with lot 1905233230.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of (b)(4).Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: according to anticoagulation techniques in apheresis, several metabolic complications other than hypocalcemia have been described with citrate administration including hypomagnesemia, metabolic alkalosis, hypokalemia, and changes in parathyroid hormone levels (pth).These metabolic complications are citrate mediated and often related to citrate infusion rates or donor characteristics.The generation of a metabolic alkalosis contributes to the development of hypokalemia.For example, the simultaneous development of metabolic alkalosis and hypokalemia, with serum potassium levels less than 3.0 meq/l, has been found to occur frequently in patients with ttp after plasma exchange.10 metabolic alkalosis directly induces hypokalemia, as high serum bicarbonate levels cause a compensatory shift of hydrogen ions out of the intracellular compartment in exchange for potassium.The concurrent presence of hypocalcemia and hypomagnesemia also contributes to the development of hypokalemia, as the development of citrate-induced hypocalcemia has been found to be strongly associated with the subsequent development of citrate-induced hypokalemia.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9525930
• MDR Text Key: 177604985
• Report Number: 1722028-2019-00441
• 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: 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: 02/08/2021; 03/25/2021; 05/05/2021; 05/25/2021
• Supplement Dates FDA Received: 02/24/2021; 04/08/2021; 05/21/2021; 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention