Catalog Number 10400 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Fever (1858); High Blood Pressure/ Hypertension (1908)
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Event Date 10/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional patient codes: pain, tachycardia and nausea.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that a replaced t cell acute lymphoblastic leukemia patient had a post transfusion reaction 5 minutes after receiving 200ml of single donor platelets (sdp).The patients reported symptoms were: fever, nausea, abdominal pain, dyspnea, cough,tachycardia, hypertension.Per the customer, the patient was given: hydro cortisol, avil,paracetamol and nebulizer for oxygen support.Per the customer the patient recovered from the event.Patient identifier and weight are 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.
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Manufacturer Narrative
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This report is being filed to provide in and corrected information in a.2.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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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