MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER AUTOPAS MULTIPLS SET

Catalog Number 80310

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

Patient Problem Reaction (2414)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Per the customer, this was a transfusion of sdp with in addition of pas of 35% plasma carryover.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a during single dose platelet (sdp) transfusions on a patient with dengue fever, the patients blood pressure (bp) lowered and the patient became hypotensive.The clinician at the customer site ordered immediate administration of adrenaline and the patient was shifted to the intensive care unit (icu) per the customer, the patient is stable and discharged.Patient age is not available at this time.The disposable set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, e.1, h6 and h10.Investigation: upon review, no reported donor reactions have been reported on this trima lot number.According to the aabb circular of information for the use of human blood and blood components (revised 2013).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 but dangerous complications requiring immediate treatment with epinephrine.These reactions have been reported in iga-deficient patients who develop antibodies to iga antibodies the run data file (rdf) was analyzed for this event.There is no evidence or suspicion of device malfunction based on the rundata file analysis.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide updated information in e.1 and h.10, and additional information in a.3, h.6 and h.10.Investigation: a disposable history search was performed for lot 1911121330.No additional reports of a similar issue were found.Updated investigation: 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 and supportive care.While these reactions have been reported in iga-deficient patients who develop antibodies to iga antibodies 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: the end of run summary showed the platelet product could not be labeled as leukoreduced and the wbc content, yield, and volume should be verified.Analysis cannot confirm whether the verification messages contributed to the reported anaphylactic reaction during transfusion.There is no evidence or suspicion of device malfunction based on the run data file analysis.A definitive root cause could not be determined.Possible causes include but are not limited to: patient's underlying other allergies patient's sensitivity ethylene oxide used to sterilize the disposable set.Patients with severe iga deficiency may develop antibody to iga and, with repeated transfusion, are at high risk of allergic reaction.Patients with haptoglobin deficiency may develop reactions that are idiosyncratic and not associated with a specific serum protein deficiency, polymorphism, or identifiable cause.Presence of donor and product attributes such as pro-allergic plasma ige or immunogenic proteins in the platelet product.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER AUTOPAS MULTIPLS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10333052
• MDR Text Key: 201922348
• Report Number: 1722028-2020-00353
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: 80310
• Device Lot Number: 1911121330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00040 YR
• Patient Weight: 68