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

Catalog Number 10225

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

Patient Problem Electrolyte Imbalance (2196)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: patient had no past medical history.Patient was hospitalized for 3 months following myasthenia crisis, with chronic respiratory failure requiring tracheotomy and mechanical ventilatory support.The management of this refractory myasthenia was based on acetylcholinesterase inhibitors, corticosteroids, rituximab, and thymectomy.After a new relapse, daily tpes were started, with 4% albumin as the replacement fluid, which had a sodium concentration of 148 mmol/l and chloride concentration of 145 mmol/l.After the second saily tpe, the patient had a hyperchloremic metabolic acidosis reaction, so every other day tpes were started.Subsequent exchanges were spaced (every other day) and performed with less volume (1.2 plasma volume).Laboratory tests performed after the next exchange showed an elevation of chloride at 110 mmol/l, but without significant acidosis.The analysis of substitution 4% albumin solution revealed a sodium concentration of 148 mmol/l and chloride concentration of 145 mmol/l.This acidosis is due to a reduction of the strong anion gap by an excessive rise of plasma chloride as well as a disproportionate renal bicarbonate elimination.Article citation: ritzenthaler, t., grousson, s., and dailler, f.Hyperchloremic metabolic acidosis following plasma exchange during myasthenia gravis crisis.Journal of clinical apheresis 31:479¿480 (2016).Published online 22 september 2015 in wiley online library (wileyonlinelibrary.Com).Investigation is in process.A follow-up report will be provided.

Event Description

Per an article in journal of clinical apheresis, a myasthenia gravis patient was started on every-other-day therapeutic exchange procedures (tpe) following a hyperchloremic metabolic acidosis reaction on daily tpes.Laboratory tests performed after the next exchange showed an elevation of chloride at 110 mmol/l, but without significant acidosis.Is unknown at this time if medical intervention was required for the elevated chloride level.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

Investigation: according to the aabb circular of information for the use of human blood components (revised 2017), other metabolic derangements can accompany rapid or large-volume transfusions, especially in patients with preexisting circulatory or metabolic problems.These include acidosis or alkalosis (deriving from changing concentrations of citric acid and its subsequent conversion to pyruvate and bicarbonate) and hyper-or hypokalemia since this was a case study of a patient from (b)(6) 2015, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: based on the author's conclusion, large volumes of 4% albumin with chloride concentration close to isotonic saline solution, leads to a higher chloride concentration, and may be responsible for hyperchloremic metabolic acidosis.

Event Description

Pursuant to eu personal data privacy laws, additional patient information is not available from the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 9830930
• MDR Text Key: 188487253
• Report Number: 1722028-2020-00113
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female