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

Catalog Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Unspecified Infection (1930)

Event Date 10/02/2014

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: yamada, c, et al.2015.Maintenance plasma exchange treatment for muscle specific kinase antibody positive myasthenia gravis patients.Journal of clinical apheresis 30:314¿319.Investigation is in process.A follow-up report will be provided.

Event Description

The article, 'maintenance plasma exchange treatment for muscle specific kinase antibody positive myasthenia gravis patients' (yamada 2015) describes a series of 3 patients who underwent repeated therapeutic plasma exchange (tpe) procedures for treatment of myasenthia gravis.Cobe spectra and spectra optia were used for tpe.Two catheter-related infections are described for one patient, which lead to pneumonia during the first instance and sepsis and pulmonary embolism during the second infection.Upon arriving at the hospital system for treatments, the patient received a total 10 tpe treatments; three times a week at the beginning and twice a week after five treatments, along with prednisone 10 mg daily with remarkable improvement of the symptoms.However, her mild dysarthria worsened again in 6 weeks.Therefore, she received eight tpe divided twice a week followed by three weekly tpe with good response.After the third weekly tpe, she developed central catheter related polymicrobial (enterobacter cloacae, klebsiella pneumonia, and coagulase negative staph) blood infection leading to pneumonia, and the catheter was removed.She then began to receive tpe treatments via an arteriovenous fistula on her right forearm.After the fistula failed, a central catheter was placed despite her history of catheter-related infection for tpe.She again developed catheter-related sepsis and pulmonary embolism in (b)(6) 2014; both were successfully treated.Patient weight is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: tpe procedures were performed using either the cobe spectra rv or spectra optia rv apheresis system (terumobct, lakewood, co), and one plasma volume was exchanged with 5% albumin in one procedure.The amount of anticoagulant citrate dextrose solution a (acd-a) was calculated by the apheresis machine using each patient¿s total blood volume calculated based on sex, height, and weight to meet the set infusion rate of 0.8¿1.0 ml/min/liter of total blood volume.About 2.4 meq ca+2 in the form of calcium gluconate or chloride was added to each 500 ml albumin bottle to prevent citrate toxicity symptoms.The patient in this report is now receiving maintenance tpe every 7¿10 days and is doing well with only mild dysphonia and fatigue as her baseline.She is on prednisone alternating 5 mg and 10 mg daily, mycophenolate mofetil 2,500 mg daily, and pyridostigmine as needed, in addition to bipap use during sleep.She has not had ptosis or diplopia.She received another fistula placement in november 2014.Investigation is in process.A follow up report will be provided.

Event Description

Since this was a retrospective study, a request for additional patient information is not feasible.

Manufacturer Narrative

Investigation: anti-muscle specific kinase antibody positive myasthenia gravis (musk mg) is often characterized by a relatively severe and progressive course, refractoriness to standard myasthenia gravis (mg) medications, and an increased risk of myasthenic crisis.The authors reported successful management of three musk mg patients using maintenance therapeutic plasma exchange (tpe) treatment for up to 4.5 years.The study was a 5-year retrospective review of all mg patients treated with tpe between 2008 and 2013 at (b)(6).Inclusion criteria of musk mg were positive for anti-musk antibodies and a diagnosis of musk mg by staff neurologists.According to therapeutic apheresis: a physician's handbook, adverse effects related to vascular access are a frequent concern.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.During a dressing change, the site should be cleaned and observed for signs of infection such as redness, swelling, drainage, and foul odor.If an infection is suspected, cvc removal should be considered, and the patient should be treated for infection as appropriate.According to cdc guidelines for the prevention of intravascular catheter-related infections: 2017, 80,000 crbsis occur in united states icus each year and a total of 250,000 cases of bsis have been estimated to occur annually, if entire hospitals are assessed.These infections independently increase hospital costs and length of stay, but have not generally been shown to independently increase mortality.This was a retrospective review of all mg patients treated with tpe between 2008 and 2013.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.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: per internal medical review and analysis, the device did not cause or contribute to the reported adverse events.Root cause: risk factors for catheter related bloodstream infection (crbsi) include patient, catheter, and operator- related conditions.The specific causes of the two reported incidents of crbsis for the patient in case 2 could not be determined; however, based on patient history of reoccurring infection, it is possible the patient had underlying susceptibilities.There are four recognized routes for contamination of catheters: 1.Migration of skin organisms at the insertion site into the cutaneous catheter tract and along the surface of the catheter with colonization of the catheter tip; this is the most common route of infection for short-term catheters.2.Direct contamination of the catheter or catheter hub by contact with hands or contaminated fluids or devices.3.Catheters become hematogenously seeded from another focus of infection; less common.4.Infusate contamination; rare.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10039858
• MDR Text Key: 196751301
• Report Number: 1722028-2020-00220
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00041 YR