MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA

Model Number 80400

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

Patient Problem Reaction (2414)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: letowska, m., et al.2016.Hemovigilance survey of pathogen-reduced blood components in the warsaw region in the 2009 to 2013 period.Transfusion.2016.56;s39¿s44.Doi:10.1111/trf.13330 investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.

Event Description

In the article, "hemovigilance survey of pathogen-reduced blood components in the warsaw region in the 2009 to 2013 period", a study evaluated data from 2007-2013 of adverse events reported to the authority before and after implementation of mirasol in 2009.Apheresis platelet and plasma products were collected using trima.None of the products had undergone mirasol treatment.Adverse events reported: 113 (85 + 28) transfusion reactions as a result of receiving platelets (not treated with mirasol) 33 transfusion reactions as a result of receiving platelets (not treated with mirasol).Anxiety, chills, fever, itching, nausea, numbness around the mouth, rash 47 (26 + 21) transfusion reactions as a result of receiving plasma (not treated with mirasol) 10 transfusion reactions as a result of receiving plasma (not treated with mirasol).Chill, fever, rash, numbness around the mouth.It is not specified in the article if medical intervention was necessary for any of these events.Specific details regarding the patients that experienced adverse events, such as patient information and outcome, were not included in the article, therefore, this report is being provided as a summary of these 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, e1, h6 & h10.Investigation: per the article, in 2009 the mirasol pathogen reduction technology (prt) was introduced to the routine blood component p roduction of the regional blood transfusion center in warsaw (rbtcw).The goal of this study was to investigate the safety of mirasol treated blood components.The accumulated passive hemovigilance data of mirasol-treated blood components collected at the rbtcw are presented and compared to historical and contemporary data.Furthermore, active hemovigilance data collected from patients with different hematologic disorders transfused with mirasol-treated or untreated blood components at the institute of hematology and transfusion medicine (ihtm) are presented and discussed.Leukoreduced pcs were produced from whole blood donation by pooling of five buffy coats in plasma using a whole blood processing system (atreus and orbisac, terumo bct, zaventem, belgium) since 2005 or by apheresis (trima accel device, terumo bct) since 2000.All pcs were stored in plasma for up to 5 days at 22oc on a platelet (plt) agitator.Ffp was separated from whole blood donation within 8 hours of collection and immediately blast-frozen to -30oc.Quarantine ffp (q-ffp) is ffp that can be released from quarantine only when the donor returns to the blood center and tests repeatedly negative for the transfusion-relevant viruses hcv, hiv-1/2, and hbv within an interval of 4 months.Cryodepleted ffp is the resulting plasma after centrifugation of thawed ffp and separation of the precipitate (cryoprecipitate).Blood components were treated with the mirasol prt system according to the manufacturer¿s instructions for use.Passive hemovigilance at the rbtcw the overall ar reporting rate after the implementation of m-pcs has been maintained at 0.39%, similar to the historical value of a 0.43% ar rate (p=0.47) reported for the period encompassing the years 2007 and 2008, before mirasol introduction at the rbtcw (table 1).Moreover, rates of ars observed during the period 2011 to 2012 after transfusion of mirasol-treated and untreated pcs were not significantly different (p=0.35).The rate of ar after transfusion of m-ffp was 0.05% and compares to 0.04% for the earlier period (2007-2008; p=0.29).In the period 2011 to 2012 there was no significant difference in rates of ar between treated and untreated ffp (p=0.66).Whereas one ar of grade iii was reported after transfusion of untreated ffp in this period, only mild reactions have been reported after transfusion of m-ffp (data not shown).In conclusion, no differences in rates of ar after transfusion of mirasol-treated and untreated components have been observed, when compared to both historical data before introduction of the mirasol technology and contemporary data (period 2011-2012).Active hemovigilance at the ihtm in 2011 the ihtm received the first m-pc from the rbtcw.In the period encompassing 2011 through 2013, a total of 12,558 pcs were transfused to patients in this hospital.All ars observed after transfusion of m-pcs were grade i severity and hence mild.The rates of ar were significantly different after transfusion of mirasol-treated or untreated pcs (0.33 and 0.70%, respectively; p=0.0037).Although a lower rate was observed in the mirasol-treated cohort, the nature of the symptoms of ars were quite similar in both groups (table 2).In 2010 the ihtm received the first m-ffp from rbtcw.In the 2010 to 2013 period 12,397 units of therapeutic plasma, including q-ffp, cryodepleted ffp, and m-ffp, were transfused to patients hospitalized in the ihtm.Out of a total of 1,855 m-ffp units transfused at the ihtm to seven patients with acquired ttp, only one allergic reaction was observed in one patient.This patient also demonstrated the same reaction outcome in a subsequent transfusion with q-ffp.The seven patients with congenital ttp were transfused with 874 units of m-ffp.One patient in this group showed signs of dyspnea and rash after transfusion of m-ffp.The treatment was switched to q-ffp without further ars.The same patient received transfusion 1 month later with an additional 20 m-ffp units and showed no reaction to these components, suggesting that the first ar was not related to the mirasol treatment.In a total of 104 patients transfused with 3929 units of m-ffp, five ars were observed and no causal relationship could be established between the mirasol treatment and these reactions.The summarized data on ars in patients treated with ffp (mirasol treated or untreated) between 2010 and 2013 are presented in table 3 for comparison.The rates of ars were not significantly different after transfusion of m-ffp and untreated ffp (0.13 and 0.12%, p=0.89).At the ihtm the adverse events (reactions) observed after transfusion of treated and untreated pcs were not different.All events were of grade i (e.G., chills) and a causality relationship with the mirasol treatment was considered unlikely.There was, however, a significant difference in rates of ars in the two groups, these being more frequent after transfusion of untreated components.It is worth noting here that both components are composed of plts stored in plasma, so the reduction of ar rates in the group of mirasol-treated components cannot be explained by a decrease of plasma protein content with the adoption of plt additive solution.7 lower rates of ars with mirasol treated components may be linked to the significant reduction of white blood cell (wbc) replication, cytokine production by residual wbcs and alloimmunization that has been shown in in vitro and animal studies.According to the aabb circular of information for the use of human blood and blood components (revised 2017).Febrile nonhemolytic reaction is typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial.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.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is in process.A follow up report will be provided.

Event Description

Pursuant to eu personal data protection laws, the patient information is not available from the customer.Information on the extent of medical intervention required, if any, is unknown.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: a definitive root cause of the febrile non-hemolytic transfusion reactions could not be determined.It is widely known that transfusion of blood components may cause febrile reactions due to leukocyte or platelet antibodies in patients who have received previous transfusions and transfusion reactions can still occur with leukocyte depletion, resulting from platelet-associated cd40l and scd40l induction of prostaglandin e2 synthesis and the synthesis of pro-inflammatory cytokines in a variety of cells in the recipient, including endothelial cells and fibroblasts.A definitive root cause of the allergic reactions could not be determined.Possible reasons for reactions related to transfusion of platelet concentrates include (i) ige and igg antibodies in the recipient against plasma proteins in the transfused blood component, (ii) transfusion of cytokines, chemokines, and histamine generated in the platelet product during preparation and storage.The best-known type of anaphylactic reaction is induced by iga deficiency of the recipient and subsequent formation of anti-iga.Patients lacking only one iga subclass may form subclass-specific anti-iga; other patients may get immunized against allotypes on the iga molecules.Patients with such antibodies of ¿limited specificity¿ usually experience less severe anaphylactic reactions than patients with complete iga deficiency and class-specific anti-iga.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL RBC PLT/PLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10420155
• MDR Text Key: 203682826
• Report Number: 1722028-2020-00386
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2020

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 Model Number: 80400
• Device Catalogue Number: 80400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 04/29/2021; 05/12/2022
• Supplement Dates FDA Received: 05/11/2021; 05/25/2022
• 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): Required Intervention; Other