MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET + SAMPLER, PLASMA, RBC SET

Model Number 82446

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

Patient Problems Dyspnea (1816); Chills (2191); Ptosis (2620)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the day she first had the bad reaction her platelet count prior to receiving the platelets was 14 after the reaction a cbc was completed in the ed and her plt count was 11 she is definitely destroying them fast.As far as the infusion materials go with both reactions the previously had received 2 units of rbc¿s with no issues using the same lot# of tubing as with the plt¿s.Per the customer, washing the platelets did not help.Hla platelets are being considered, however the reactions noted have not resembled hla antibody / hla antigen reaction.According to the aabb circular of information for the use of human blood and blood components (revised 2017).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.A disposable history search confirmed there were no occurrences of a similar issue reported on this lot worldwide.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a patient receiving platelets has had 2 severe allergic reactions to the plastic inside the platelet bag.The week prior, the patient had a severe reaction with jaw pain and drooping, chills, hives, difficulty breathing and required o2 and received an epi pen injection.She was also taken to the er and admitted for a couple of days.It was ultimately deemed to be an allergic transfusion reaction.The customer asked if the material in the bag which allows the bag to breathe has caused allergic reactions in other patients.Customer support informed her she is correct, the platelet bags are different which allows gas exchanges.The bags are citrated vinyl.Full patient identifier: (b)(6).Patient weight is not available at this time.This report is for the first of the two reactions.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide and corrected information in a.1.Investigation: the second of the two reactions was captured on mdr#1722028-2021-00102.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Terumo bct clinical support contacted the customer to request patient iga and hla antibody testing.The iga test passed with a value in the acceptable range.Serologic tests confirmed the presence of class i hla alloimmunization.According to 'reactions induced by platelet transfusions', febrile non-hemolytic transfusion reactions (fnhtrs) are common in recipients of platelet concentrates.Patients with isolated febrile reactions may otherwise be asymptomatic or may experience rigor and chills.As these reactions usually have no serious long-term effects, they are often not reported and documented as transfusion reactions.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.The incidence for nonhemolytic transfusion reactions is estimated to be as high as 30% of platelet transfusions.Updated investgation: per 2017 aabb circulation of information, platelets bear a variety of antigens, including hla and platelet-specific antigens.Patients transfused with platelets often develop hla antibodies.The patient may become refractory to incompatible platelets.When platelets are transfused to a patient with an antibody specific for an expressed antigen, the survival time of the transfused platelets may be markedly shortened.Per the aabb therapeutic apheresis: a physician's handbook, the rate of adverse events during therapeutic apheresis is 4-5%, with most complications being minor and well tolerated.Per the handbook, transfusion reactions occur with a 1.6% frequency.Root cause: a definitive root cause for the febrile non-hemolytic transfusion reaction (fnhtr) is blieved to be related to the patient developing class i antibodies against hla antigens found in the surface of platelets/wbcs from prior transfusions.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET + SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11439403
• MDR Text Key: 238588013
• Report Number: 1722028-2021-00103
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Device Lot Number: 2009164251
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACDA LOT #: 20044080
• Patient Outcome(s): Other
• Patient Age: 00073 YR
• Patient Weight: 90