MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA PLATELET PLASMA

Catalog Number 10400

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

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Anxiety (2328)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a post allogenic stem cell transplant sickle cell disease patient had a reaction six minutes after being transfused with 250 ml of single donor platelets (sdp).Reported symptoms included: anxiety, restlessness, abdominal pain, dyspnea and hypertension.Per the customer, necessary preventive action was taken immediately.The medications given included: hydro cortisol, avil and nebulizer for oxygen support.Per the customer the patient recovered from the event.Patient identifier and weight 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 in investigation: per the customer, a specific reason for the reaction was not identified.The customer did not suspect the transfusion reaction was related to the optia device.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to 'reactions induced by platelet transfusions', febrile non-hemolytic transfusion reactions (fnhtrs) are common in recipients of platelet concentrates.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.Allergic and anaphylactic reactions occur after platelet transfusions with similar frequency as fnhtrs.The risk of allergic reactions is between 0.09 and 21% in patients who receive platelet transfusions.Allergic reactions are highly variable in severity.Manifestations may occur as isolated pruritus and urticaria as the only dermal manifestations.Systemic reactions may include bronchoconstriction, hypotensive reactions and shock.Citation: kiefel, v.(2008).Reactions induced by platelet transfusions.Transfusion medicine and hemotherapy, 35(5), 354-358.Doi:10.1159/000151350 investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in root cause: based on the clinical information provided, a definitive root cause for the transfusion reactions could not be determined.Possible causes include, but are not limited to: - leukocyte or platelet antibodies from previous transfusions.- platelet-associated induction of prostaglandin e2 synthesis and the synthesis of pro-inflammatory cytokines.- leukocytes present in the product.- ige and igg antibodies in the recipient against plasma proteins in the transfused blood component.- transfusion of cytokines, chemokines, and histamine generated in the platelet product during preparation and storage.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA PLATELET PLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9238974
• MDR Text Key: 164642128
• Report Number: 1722028-2019-00314
• Device Sequence Number: 1
• Product Code: LKN
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 10400
• Device Lot Number: 1902283330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/15/2019; 12/03/2019
• Supplement Dates FDA Received: 11/19/2019; 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROMSON BT SET WAS USED FOR TRANSFUSION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00009 YR
• Patient Weight: 30