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

Catalog Number 70500

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Electrolyte Imbalance (2196); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: sharma, r., hans, r., takkar, a., sankhyan, n., goyal, m., lal, v.Efficacy of therapeutic plasma exchange in neuromyelitis optica spectrum disorders experience from tertiary care centre in north india.Vox sanguinis.2019.114:114 investigation is in process.A follow-up report will be provided.

Event Description

The abstract, "efficacy of therapeutic plasma exchange in neuromyelitis optica spectrum disorders experience from tertiary care centre in north india" described a study aimed to assess the efficacy of tpe in symptomatic patients of neuromyelitis optica spectrum disorders (nmosd) not responding to high dose of intravenous steroids.Adverse events were observed in 13.2% (23/174) of the procedures; hypotension as the most common event (n = 12) followed by allergic reactions to replacement fluid (n-5), hypocalcemia (n = 3) and i.V.Line infection (n = 3).One patient had relapse and underwent second tpe cycle and four did not showed any improvement post therapy.Exact details, such as patient information and required medical intervention, were not included in the abstract, therefore, this report is being filed as summary of the events.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 b.5, e.1, h.6, and h.10.Investigation: per the article, tpes were done on using 5% human serum albumin or fresh frozen plasma as replacement fluid.The mean number of procedures done was 4.97 +/- 2.08 replacing 1 to 1.5 plasma volume during the procedures.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (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.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.According to the aabb circular of information for the use of human blood components (revised 2017), allergic reactions frequently occur (ie, 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually respond to antihistamines.More severe manifestations, including respiratory and cardiovascular symptoms, are more consistent with anaphylactoid/anaphylactic reactions and may require more aggressive therapy (see below).No laboratory procedures are available to predict these reactions.Anaphylactic reactions, characterized by hypotension, tachycardia, nausea, vomiting and/or diarrhea, abdominal pain, severe dyspnea, pulmonary and/or laryngeal edema, and bronchospasm and/or laryngospasm, are rare (<10/100,000 transfused units) but dangerous complications requiring immediate treatment with epinephrine.While these reactions have been reported in iga-deficient patients with anti-iga antibodies and patients with haptoglobin deficiency, most reactions are idiosyncratic and not associated with a specific serum protein deficiency, polymorphism, or identifiable cause.Dhr details: since this retrospective study was to assess the efficacy of therapeutic plasma exchange in nmosd patients over a period of six years (2013¿2019), 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: a specific root cause for the reported citrate reactions could not be determined.These reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the acd infusion.The authors attributed the allergic reactions to the replacement fluids.A specific root cause for the reported hypotension could not be determined.Possible causes include, but are not limited to, patient sensitivity to the hemodynamic stress of the procedure, patient disease state, and or concomitant medications.

Event Description

The retrospective study was to assess the efficacy of therapeutic plasma exchange in nmosd patients over a period of six years (2013¿2019).A request for specific patient information is not feasible.The mean age of the patients was 28.654 +/- 16.39 years with a male:female ratio of 0.29:1.The authors did not specify if any medical intervention was required to mitigate any of the adverse reactions.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11473739
• MDR Text Key: 244783162
• Report Number: 1722028-2021-00107
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: BK080035
• Number of Events Reported: 23
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/20/2022
• 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