MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA TPE SET

Catalog Number 70500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rash (2033)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry date not available at this time.Article citation: naik, a., prakash, s., ray, g.K., satpathy, a.K., mukherjee, s.Variable response to therapeutic plasma exchange in pediatric anti-nmda receptor encephalitis.Transfusion clinique et biologique : journal de la societe francaise de transfusion sanguine.2021.Investigation is in process.A follow-up report will be provided.

Event Description

The journal article, "variable response to therapeutic plasma exchange in pediatricanti-nmda receptor encephalitis" presents a retrospective analysis of four case reports that investigated the use of tpe on four patients with a severe form of encephalitis due to anti-nmda receptor antibody.Plasma exchange was performed using the cobe spectra version 7.0 with 5% albumin and fresh frozen plasma (ffp) being used as replacement fluids.A total of 20 procedures were performed on 3 female and 1 male patient aged 9-14 years (bodyweight: 18- 40kg).Anti-nmdr encephalitis patients were initially managed via first-line immunotherapy (iv methylprednisolone and ivig).Tpe was only initiated when patients failed to respond to the primary therapy like corticosteroid and ivig.Out of the 20 procedures, one female patient experienced adverse events on the second tpe procedure.The patient reported an allergic reaction (papular rash) with hypotension.In this case, the adverse reactions were managed via switching the replacement fluid from ffp to 5% albumin solution.The authors state that there is no standard treatment protocol for anti-nmdar encephalitis, and that "tpe is a safe treatment option in pediatric anti-nmdar encephalitis as minimal and manageable adverse reactions are observed." the patient who experienced the allergic reaction presented with focal seizure and urinary and fecal incontinence.She was also being treated with omnacortil, lorazepam, phenytoin, valproate, phenobarbiton, dopamine, ivig.The article reported that at follow up, the patient died one month after discharge.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: anti-nmda receptor encephalitis in an acute form and generally presents with abnormal movements and psychiatric symptoms.Therapeutic plasma exchange (tpe) is the first line of treatment for anti-nmdar encephalitis according to the recent asfa category and 5-12 tpe procedures is recommended for 60-70% improvement.This report highlights the role of plasma exchange in anti-nmda receptor encephalitis in pediatric patients.Anti-nmdr encephalitis patients were initially managed via first-line immunotherapy (iv methylprednisolone and ivig).Tpe was only initiated when patients failed to respond to the primary therapy like corticosteroid and ivig.Tpe was performed on an alternate day using the cobe spectra.The replacement fluid was either fresh frozen plasma (ffp) and 0.9% normal saline.Ffp was used as replacement fluid.Before tpe, laboratory parameters like complete blood count (cbc), coagulation profile, liver function test (lft), renal function test (rft), ionized calcium were evaluated.Vascular access was established by inserting an in dwelling double lumen catheter into the femoral vein.Total blood volume was calculated using glicher¿s rule of five according to their body build.Approximately one plasma volume was exchanged in each procedure.Acid-citrate-dextrose-a (acd-a) was used as an anticoagulant for the tpe procedure.Inj.Calcium gluconate (10% w/v) was dissolved in 100 ml normal saline and infused slowly for every 1000 ml of plasma exchanged to prevent hypocalcemia.At the tpe procedure initiation, the tubing sets were primed with group-specific coomb¿s crossmatched red blood cell unit if the extracorporeal volume is more than 10% of total blood volume (tvb) to prevent hypotension.The heart rate, pulse rate, blood pressure, spo2, and temperature were constantly monitored during the procedure.If any adverse transfusion reactions occurred, injection pheniramine maleate 22.75 mg i.M, i.V hydrocortisone 50-100 mg was used as per bodyweight whenever indicated.The central line was taken care of properly to prevent any complications like hemorrhage, infection, or signs of venous thrombosis and so also flushed with heparin twice daily.Cbc, lft, serum electrolytes, pt, aptt, were repeated after each tpe procedure.The patient's adverse reaction was managed by switching the replacement fluid from ffp to 5% albumin solution.It is unclear if she received pheniramine maleate or hydrocortisone for symptoms.In general, response of therapy in these patients was not observed immediately after tpe procedures as antibody in the cerebrospinal fluid (csf) are associated with unsatisfactory neurological outcome and longer response time to treatment.The authors concluded that there is no standard treatment protocol for anti-nmdar encephalitis, and that "tpe is a safe treatment option in pediatric anti-nmdar encephalitis as minimal and manageable adverse reactions are observed." the exact order of various treatment options, such as corticosteroids and ivig or tpe is not well defined.Still, tpe should be considered prior to ivig for rapid improvement and a better outcome.Slower recovery rate and variable response to tpe need further study of a large number of cases.Procedure and outcome details for case-3 number of procedures: 5 hb gm/dl (mean ± sd): (10.3 ± 1.1) hct % (mean ± sd): (31.2 ± 2.9) tbv (ml): 1750 pv (ml): (mean ± sd): (1202 ± 39.3) volume removed in ml (mean ± sd): (1510 ± 65.3) vol.Replaced in ml (mean ± sd): (1255 ± 39.7) acd vol.Used ml (mean ± sd): (260 ± 36.6) exchange time minutes (mean ± sd): (154 ± 22.8) pt/aptt: 11.3/23.4 priming: no replacement fluid: albumin days from 1st sign symptom to hospital admission: 24 days from hospital admission to 1st tpe: 20 days clinical outcome at discharge: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance (mrs 4).Clinical outcome at follow up: death after 1 month of discharge hospital stay duration: 62 days according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.(see pages 28-33.) the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.Since this was a retrospective analysis, a request for the lot number is not practical.All lots must meet acceptance criteria for release.This product has been validated to achieve less than 6mg eto, meeting the requirements of iso 10993-7 prior to release and less than 1ppm in the collect bag at the time of use.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h6 & h10.Investigation: out of the 20 procedures, one female patient experienced an adverse event (papular rash with hypotension) on the second tpe procedure, an allergic transfusion reaction to the ffp.Custom prime was not performed prior to this procedure.In this case, the adverse reaction was managed via switching the replacement fluid from ffp to 5% albumin solution.Root cause: based on the author's statements, the patient's allergic reaction was caused by a response to the ffp.The hypotension was likely related to the patient's allergic response and/or disease state.According to the authors, these anti-nmdar encephalitis patients may present with hypotension during the procedure due to accompanying autonomic dysfunction.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11894625
• MDR Text Key: 261921199
• Report Number: 1722028-2021-00192
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

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 Catalogue Number: 70500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 07/08/2021; 07/26/2021
• Supplement Dates FDA Received: 07/12/2021; 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00011 YR
• Patient Weight: 25