|
Catalog Number 80370 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
|
Patient Problems
Itching Sensation (1943); Urticaria (2278)
|
Event Date 01/28/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Investigation: per the customer, the patient was a recipient of a platelet transfusion derived using the isoplate research protocol.According to the aabb technical manual, 16th edition, pages 195-197, adverse reactions seen at the time of donation or those reported later average about 3.5%.The trima accel operator¿s manual instructs the operator to be aware of possible adverse effects and how to manage them.Investigation is in process.A follow-up report will be provided.
|
|
Event Description
|
Upon review of a patient's chart by the clinical research associate at the customer's site, it was discovered that during a clinical research study, a patient experienced a mild transfusion reaction.The patient developed hives and complained of itching.Per attending physician's order, the patient was given hydrocortisone via iv.Per the customer, the patient recovered to baseline prior to the transfusion.The customer declined to provide patient weight.The trima accel disposable set is not available for return because it was discarded by the customer.
|
|
Manufacturer Narrative
|
This report is being filed to provide additional information.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Investigation is still in process.A follow-up report will be provided.
|
|
Manufacturer Narrative
|
Per literature review, "reactions induced by platelet transfusions," allergic reactions occur with a frequency between 0.09% to 21% of patients that receive platelet transfusions.The article also states that allergic reactions are variable in severity and can display as skin manifestations (hives and itching) to systemic reactions such as bronchoconstriction,hypotensive reactions and shock.Root cause: a definitive root cause for the recipient's reaction could not be determined.Possible causes for allergic reactions related to platelet transfusions include ige and igg antibodies in the transfusion recipient against plasma proteins in the blood product or transfusion of cytokines and histamines generated in the platelet product during blood product preparation and storage.Citation:kiefel, v.(2008).Reactions induced by platelet transfusions.Transfusion medicine and hemotherapy, 35(5), 354¿358.Http://doi.Org/10.1159/000151350.
|
|
Search Alerts/Recalls
|
|
|