Investigation: per the customer, the day she first had the bad reaction her platelet count prior to receiving the platelets was 14 after the reaction a cbc was completed in the ed and her plt count was 11 she is definitely destroying them fast.As far as the infusion materials go with both reactions the previously had received 2 units of rbc¿s with no issues using the same lot# of tubing as with the plt¿s.Per the customer, washing the platelets did not help.Hla platelets are being considered, however the reactions noted have not resembled hla antibody / hla antigen reaction.Investigation is in process.A follow-up report will be provided.
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The customer reported a patient receiving platelets has had 2 severe allergic reactions to the plastic inside the platelet bag.For the second reaction, the patient returned to the cancer center to receive platelets again.They ordered washed platelets for her; she received the entire unit then begin to have jaw pain & drooping, headache and chills the nurses gave her o2 this time as well along with some other medications.She recovered at the cancer center and did not have to be brought to the er.The customer asked if the material in the bag which allows the bag to breathe has caused allergic reactions in other patients.Customer support informed her she is correct, the platelet bags are different which allows gas exchanges.The bags are citrated vinyl.Full patient identifier: (b)(6).Patient weight is not available at this time.This report is for the second of the two reactions.The disposable set is not available for return because it was discarded by the customer.
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This report is being filed to provide additional information in a.4, h.6, and h.10 and corrected information in a.1.Investigation: the first of the two reactions was captured on mdr#1722028-2021-00103.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable history search confirmed there were no occurrences of a similar issue reported on this lot worldwide.Terumo bct clinical support contacted the customer to request patient iga and hla antibody testing.The iga test passed with a value in the acceptable range.Serologic tests confirmed the presence of class i hla alloimmunization.Per 2017 aabb circulation of information, platelets bear a variety of antigens, including hla and platelet-specific antigens.Patients transfused with platelets often develop hla antibodies.The patient may become refractory to incompatible platelets.When platelets are transfused to a patient with an antibody specific for an expressed antigen, the survival time of the transfused platelets may be markedly shortened.Per the aabb therapeutic apheresis: a physician's handbook, the rate of adverse events during therapeutic apheresis is 4-5%, with most complications being minor and well tolerated.Per the handbook, transfusion reactions occur with a 1.6% frequency.According to 'reactions induced by platelet transfusions', febrile non-hemolytic transfusion reactions (fnhtrs) are common in recipients of platelet concentrates.Patients with isolated febrile reactions may otherwise be asymptomatic or may experience rigor and chills.As these reactions usually have no serious long-term effects, they are often not reported and documented as transfusion reactions.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.Citation: kiefel, v.(2008).Reactions induced by platelet transfusions.Transfusion medicine and hemotherapy, 35 (5), 354-358.Https://doi.Org/10.1159/000151350 root cause: a definitive root cause for the febrile non-hemolytic transfusion reaction (fnhtr) is believed to be related to the patient developing class i antibodies against hla antigens found on the surface of platelets/wbcs from prior transfusions.
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