MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLASMA,ISBT SET

Model Number 80300

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

Patient Problem Reaction (2414)

Event Date 02/22/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an allergic/hypotensive transfusion reaction during single dose platelet (sdp) transfusions on a patient with thrombocytopenia post chemotherapy due to cancer return.The clinician at the customer site ordered administration of antihistamines, steroids and beta blockers.Per the customer, the patient is normal.Patient gender is not available at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Upon review, no reported donor reactions have been reported on this trima lot number.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.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 investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: a disposable history search was performed for this lot.One additional report of a similar issue from the same customer was found.That event was reported on mdr 1722028- 2020-00350 and 1722028-2020-00351.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: 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.- 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 ACCEL PLT,PLASMA,ISBT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10332885
• MDR Text Key: 201922655
• Report Number: 1722028-2020-00352
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• 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 Model Number: 80300
• Device Catalogue Number: 80300
• Device Lot Number: 1911044151
• 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: 00068 YR
• Patient Weight: 70