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

Catalog Number 70700

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 10/20/2019

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time investigations: per the abstract, even though there was a significant increase in number of rces performed over the years and associated aes, these were predominantly mild or grade i.Importantly, there were no notable increases in grade ii or iii aes.Therefore, despite increases in number of rces performed, thorough evaluation of patients prior to rce resulted in increased mild aes without increases in more severe presentations.2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016, 2017, 2018.No.Of rces: 45, 58, 93, 83, 70, 70, 72, 113, 132, 150, 299, 446.Ae rates (%): 8.9, 5.2, 8.6, 0, 4.3, 0, 2.8, 9.7, 6.1, 2.7, 15.4, 7.2.Grade i aes: 3, 2, 6, 0, 1, 0, 2, 7, 7, 3, 42, 27.Grade ii aes: 1, 0, 1, 0, 1, 0, 0, 4, 0, 1, 4, 5.Grade iii aes: 0, 1, 1, 0, 1, 0, 0, 0, 1, 0, 0, 0.Citation: kundrapu, s, et al.2019.P-ta-1: adverse events associated with red cell exchange procedures: a twelve- year experience at a tertiary academic medical center.Retrieved from: https://aabb.Confex.Com/aabb/ 2019/meetingapp.Cgi/paper/5485.Investigation is in process.A follow-up report will be provided.

Event Description

Per an aabb conference abstract from 2019, titled 'p-ta-1: adverse events associated with red cell exchange procedures: a twelve-year experience at a tertiary academic medical center', a retrospective study (2007 to 2018) of red cell exchange (rce) procedures was performed.During this period, rce was performed using cobe spectra (software versions 4.7 and 6.1) and since 2013 the spectra optia apheresis system (version 8.0).Aes were stratified based on severity of symptoms and level of intervention required as grade i (mild reactions like citrate effect and mild allergic reactions), grade ii (moderate reactions like hypotension), grade iii (severe reactions like persistent allergic reactions, hemodynamic instability) and grade iv (fatal).A total 1631 rce procedures were performed.The overall ae incidence was 7.4% (121/1631 procedures).Significant correlation was noted between number of rce and aes (spearman rho 0.7, p=0.01) and also between number of rce and mild/grade i aes (spearman rho 0.7, p=0.008).However, there was no significant correlation between number of rces and moderate/grade ii (spearman rho 0.6, p=0.06) or severe/ grade iii aes (spearman rho -0.2, p=0.5).There were no fatal/grade iv aes reported.Majority of aes 100/121 (82.6%) were grade i which were predominantly due to citrate effect followed by mild allergic reactions.Grade ii were 14% (17/121) and grade iii were 2.3% (4/121).On cobe spectra, the following aes were reported: 12 grade i (mild reactions like citrate effect and mild allergic reactions) 3 grade ii (moderate reactions like hypotension) 3 grade iii (severe reactions like persistent allergic reactions, hemodynamic instability).No information was provided in the abstract about medical intervention for these reactions.Specific details, including patient information and outcome were not included in the abstract, therefore this report is being provided as a 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 e.1, g.4, h.6 and h.10.Root cause: a definitive root cause for the reported patient reactions could not be determined.Possible causes for citrate reactions include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.Possible causes for allergic reactions include but are not limited to replacement fluid, concurrent medications, or ethylene oxide from sterilization processes.Possible causes for hypotension reactions include but are not limited to patient disease state and/or patient sensitivity to the procedure.Corrected attachment: the attachment provided in the intial mdr was incorrect, the correct article has been attached to this submission.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, e.1 and h.10.Investigation: the abstract states that a majority of the reactions were mild; however, it is unknown if the symptoms resolved on their own, resolved with basic first aid measures, or if they required medical intervention.Since this was a retrospective study for rbcx procedures between 2007 and 2018, the lot numbers were not provided; therefore, dhr searches could not be conducted for the reported adverse events.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic apheresis procedures with a frequency of 4.8% and during erythrocytapheresis procedures with a frequency of 10.0%.Therapeutic apheresis procedures may lead to major physiologic changes including hypocalcemia caused by citrate infusion, hemodynamic changes associated with fluid shifts, and depletion of cellular and plasma constituents.Allergic reactions, vasovagal reactions, problems related to access issues, hemolysis, clotting, and air embolism are also common adverse events.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.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.Transient hypotension is one of the most common reactions associated with apheresis and is usually well tolerated.The following progression is often observed: pallor and sweating begin, with the skin turning cold, the pulse slows strikingly, the blood pressure decreases, followed by nausea.Investigation is in process.A follow up report will be provided.

Event Description

Since this was a retrospective study of red cell exchange procedures over a 12 year period (2007-2018); a request for patient information is not feasible.Retrospective chart reviews are exempt from irb approval and oversight if the research involves the collection or study of existing data, documents, records, pathological specimens, the diagnostic specimens, and the data sources are publicly available, and the data is recorded by the researcher in an anonymous manner such that subjects cannot be identified directly or through identifiers linked to the subject; therefore, it is generally not possible to determine which data belong to a patient, once the data have been recorded.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA RBCX SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9996179
• MDR Text Key: 197985753
• Report Number: 1722028-2020-00183
• 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: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 70700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other