MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLATELET PLASM RBC AUTOP

Model Number	80410
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a patient had an allergic transfusion reaction after they were transfused with platelet products collected on trima.The product was collected on (b)(6) 2023 (pas), and transfused on (b)(6) 2023.Patient information and outcome are not available at this time.The set is not available for return for evaluation.
Additional Manufacturer Narrative
Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, e.1, h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.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.Root cause: a root cause assessment was performed for the allergic reactions.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * hypersensitivity to the ethylene oxide used to sterilize the disposable set.* hypersensitivity to the components inside the disposable set.* anaphylactic 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.* immediate hypersensitivity reaction via production of ige antibodies in response to allergens in the transfused product.* passive sensitization via passive transfer of donor allergens or donor antibodies (e.G.Allergen-specific ige); transient allergic sensitivity to allergens.
Event or Problem Description
The customer reported that a patient had an allergic transfusion reaction after they were transfused with platelet products collected on trima.The product was collected on (b)(6) 2023 (pas), and transfused on (b)(6) 2023.The customer declined to provide procedural details, patient information, and patient outcome.The set is not available for return for evaluation.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA LRS PLATELET PLASM RBC AUTOP
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 16599407
• Report Number: 1722028-2023-00116
• Device Sequence Number: 11158935
• Product Code: GKT
• UDI-Device Identifier: 05020583804104
• UDI-Public: 05020583804104
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2024
• Device Model Number: 80410
• Device Catalogue Number: 80410
• Device Lot Number: 2204283230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown