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| Model Number 82446 |
| Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Hypersensitivity/Allergic reaction (1907)
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| Event Date 12/01/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation: lot number and expiry were not provided.No deaths were associated with transfusion of csp units.Two of the patients who did not survive were on venous¿arterial extracorporeal membrane oxygenation (ecmo), one had post-operative complications after a fifth ileus operation and the fourth patient had an untreatable cancer diagnosis.No transfusion reactions were attributed to csp units.However, a young patient with postoperative bleeding developed transfusion-associated lung injury (trali) with symptoms starting after an emergency transfusion with two units of packed red cells.This patient underwent an emergency reoperation shortly after where he received additional transfusions of three units of packed red cells, two units of plasma, and one unit of csp.A postoperative chest radiography demonstrated bilateral opacities of the lungs.The attending anesthesiologist suspected trali which was confirmed by the immunohematology senior consultant.However, since silent hypoxia started before the transfusion of csp, they were not considered the cause of the transfusion reaction per the article, the majority of patients who underwent surgery are expected to have a fluid overload post-operatively compared to pre-operatively.This can explain the reduced plt and hgb at the end of the transfusion episode.Since this is a study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Journal article: braathen, et al.: implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored apheresis platelets for treatment of actively bleeding patients.Transfusion.2022;1¿10.An investigation was conducted for this study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021.A total of 276 cold-stored apheresis platelets (csp) units was produced and 186 units were transfused to 92 patients.No deaths were associated with transfusion of csp units.Two of the patients who did not survive were on venous¿arterial extracorporeal membrane oxygenation (ecmo), one had post-operative complications after a fifth ileus operation and the fourth patient had an untreatable cancer diagnosis.No transfusion reactions were attributed to csp units.However, a young patient with postoperative bleeding developed transfusion-associated lung injury (trali) with symptoms starting after an emergency transfusion with two units of packed red cells.This patient underwent an emergency reoperation shortly after where he received additional transfusions of three units of packed red cells, two units of plasma, and one unit of csp.A postoperative chest radiography demonstrated bilateral opacities of the lungs.The attending anesthesiologist suspected trali which was confirmed by the immunohematology senior consultant.However, since silent hypoxia started before the transfusion of csp, they were not considered the cause of the transfusion reaction.During the study period, our department documented ten transfusion reactions to room temperature stored pcs, five mild allergic reactions, three transfusion associated circulatory overload (taco) reactions, one febrile reaction, and one anaphylactic reaction.For the patients with active bleeding there was a reduction in mean plt and hbg measured before and within 24 h after issue of the first csp unit (table 2).For these ten patients mean plt declined from 121 x 109/l (56, 187, 5¿280) to 115 x 109/l (75, 155, 5¿201) after transfusion of csp, while hgb increased from 9.2 g/dl (7.9, 10.6, 5.6¿11.8) to 9.4 g/dl (8.4, 10.4, 8.0¿13.1).Blood loss measured as chest drain output until 08:00 am the next morning was measured for the 65 patients who had thoracic drains post-operatively.There was a median blood loss of 800 ml (480¿1570, 180¿ 10,810).Plt declined similarly for these 65 patients from mean 187 x 109/l (168, 206, 31¿394) pre-operatively to 127 x 109/l (114, 140, 44¿290) post-operatively while hgb declined from 10.0 g/dl (9.4, 10.5, 5.6¿16.1) to 9.4 g/dl (9.1, 9.6, 7.6¿11.4).The majority of patients who underwent surgery are expected to have a fluid overload post-operatively compared to pre-operatively.This can explain the reduced plt and hgb at the end of the transfusion episode.According to the aabb circular of information for the use of human blood components (revised 2017), transfusion-related acute lung injury (trali) is characterized by the acute onset of hypoxemia and noncardiogenic pulmonary edema within 6 hours of a blood or blood component transfusion in the absence of other causes of acute lung injury or circulatory overload.Various stimuli in blood components, most commonly white blood cell (wbc) antibodies from donors sensitized during pregnancy or prior transfusion or transplantation, or proinflammatory molecules that accumulate in stored blood components may cause trali.These mechanisms may not be mutually exclusive and may act synergistically with underlying patient factors to lead to a final common pathway of acute lung injury.These stimuli may trigger an inflammatory response, granulocyte activation and degranulation, and injury to the alveolar capillary membrane and the development of permeability pulmonary edema.Although most trali cases are associated with donor antileukocyte antibodies, rare cases have implicated recipient antileukocyte antibodies that reacted with donor leukocytes.Widespread leukoreduction of blood components has likely mitigated this latter risk.Laboratory testing of blood donors for antileukocyte antibodies or blood components for biological mediators does not alter management of this reaction, which is diagnosed on clinical and radiographic findings.Treatment of trali involves aggressive preferential use of plasma collected from male donors has been associated with a significant reduction in the number of reported trali cases and associated fatalities.According to the aabb circular of information for the use of human blood and blood components (revised 2017), allergic reactions frequently occur (ie, with 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually responds to antihistamines.More severe manifestations, including respiratory and cardiovascular symptoms, are more consistent with anaphylactoid/anaphylactic reactions and may require more aggressive therapy.No laboratory procedures are available to predict these reactions.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.While these reactions have been reported in iga-deficient patients 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.According to the aabb circular of information for the use of human blood and blood components (revised 2017), transfusion-associated circulatory overload (taco) is a frequent complication of transfusion leading to cardiogenic (hydrostatic) pulmonary edema and can occur after transfusion of excessive volumes or at excessively rapid rates.This is a particular risk in individuals with underlying cardiopulmonary or renal disease, the very young and the elderly, and in patients with chronic severe anemia in who low red cells mass is associated with high plasma volume.Small transfusion volumes can precipitate symptoms in at-risk patients who already have a positive fluid balance.Pulmonary edema should promptly and aggressively treated, and infusion of colloid preparations, including plasma components and the supernatant fluid in cellular components, reduced to a minimum.According to the aabb circular of information for the use of human blood components (revised 2017), febrile nonhemolytic reactions are typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimmunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial.Investigation is in process, a follow-up report will be provided.
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Event Description
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The article, "implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored apheresis platelets for treatment of actively bleeding patients", describes a study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021.A total of 276 cold-stored apheresis platelets (csp) units was produced and 186 units were transfused to 92 patients.During the study period, their department documented ten transfusion reactions to room temperature stored pcs, five mild allergic reactions, three transfusion associated circulatory overload (taco) reactions, one febrile reaction, and one anaphylactic reaction.For the patients with active bleeding there was a reduction in mean plt and hbg measured before and within 24 h after issue of the first csp unit (table 2).For these ten patients mean plt declined from 121 x 109/l (56, 187, 5¿280) to 115 x 109/l (75, 155, 5¿201) after transfusion of csp, while hgb increased from 9.2 g/dl (7.9, 10.6, 5.6¿11.8) to 9.4 g/dl (8.4, 10.4, 8.0¿13.1).Blood loss measured as chest drain output until 08:00 am the next morning was measured for the 65 patients who had thoracic drains post-operatively.There was a median blood loss of 800 ml (480¿1570, 180¿ 10,810).Plt declined similarly for these 65 patients from mean 187 x 109/l (168, 206, 31¿394) pre-operatively to 127 x 109/l (114, 140, 44¿290) post-operatively while hgb declined from 10.0 g/dl (9.4, 10.5, 5.6¿16.1) to 9.4 g/dl (9.1, 9.6, 7.6¿11.4).This is a study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021.A request for specific donor information is not feasible.The disposable sets are not available for return from the customer.
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Manufacturer Narrative
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Investigation: no deaths were associated with transfusion of csp units.Two of the patients who did not survive were on venous¿arterial extracorporeal membrane oxygenation (ecmo), one had post-operative complications after a fifth ileus operation and the fourth patient had an untreatable cancer diagnosis.No transfusion reactions were attributed to csp units.However, a young patient with postoperative bleeding developed transfusion-associated lung injury (trali) with symptoms starting after an emergency transfusion with two units of packed red cells.This patient underwent an emergency reoperation shortly after where he received additional transfusions of three units of packed red cells, two units of plasma, and one unit of csp.A postoperative chest radiography demonstrated bilateral opacities of the lungs.The attending anesthesiologist suspected trali which was confirmed by the immunohematology senior consultant.However, since silent hypoxia started before the transfusion of csp, they were not considered the cause of the transfusion reaction per the article, the majority of patients who underwent surgery are expected to have a fluid overload post-operatively compared to pre-operatively.This can explain the reduced plt and hgb at the end of the transfusion episode.Since this is a study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Journal article: braathen, et al.: implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored apheresis platelets for treatment of actively bleeding patients.Transfusion.2022;1¿10.An investigation was conducted for this study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021.A total of 276 cold-stored apheresis platelets (csp) units was produced and 186 units were transfused to 92 patients.No deaths were associated with transfusion of csp units.Two of the patients who did not survive were on venous¿arterial extracorporeal membrane oxygenation (ecmo), one had post-operative complications after a fifth ileus operation and the fourth patient had an untreatable cancer diagnosis.No transfusion reactions were attributed to csp units.However, a young patient with postoperative bleeding developed transfusion-associated lung injury (trali) with symptoms starting after an emergency transfusion with two units of packed red cells.This patient underwent an emergency reoperation shortly after where he received additional transfusions of three units of packed red cells, two units of plasma, and one unit of csp.A postoperative chest radiography demonstrated bilateral opacities of the lungs.The attending anesthesiologist suspected trali which was confirmed by the immunohematology senior consultant.However, since silent hypoxia started before the transfusion of csp, they were not considered the cause of the transfusion reaction.During the study period, our department documented ten transfusion reactions to room temperature stored pcs, five mild allergic reactions, three transfusion associated circulatory overload (taco) reactions, one febrile reaction, and one anaphylactic reaction.For the patients with active bleeding there was a reduction in mean plt and hbg measured before and within 24 h after issue of the first csp unit (table 2).For these ten patients mean plt declined from 121 x 109/l (56, 187, 5¿280) to 115 x 109/l (75, 155, 5¿201) after transfusion of csp, while hgb increased from 9.2 g/dl (7.9, 10.6, 5.6¿11.8) to 9.4 g/dl (8.4, 10.4, 8.0¿13.1).Blood loss measured as chest drain output until 08:00 am the next morning was measured for the 65 patients who had thoracic drains post-operatively.There was a median blood loss of 800 ml (480¿1570, 180¿ 10,810).Plt declined similarly for these 65 patients from mean 187 x 109/l (168, 206, 31¿394) pre-operatively to 127 x 109/l (114, 140, 44¿290) post-operatively while hgb declined from 10.0 g/dl (9.4, 10.5, 5.6¿16.1) to 9.4 g/dl (9.1, 9.6, 7.6¿11.4).The majority of patients who underwent surgery are expected to have a fluid overload post-operatively compared to pre-operatively.This can explain the reduced plt and hgb at the end of the transfusion episode.According to the aabb circular of information for the use of human blood components (revised 2017), transfusion-related acute lung injury (trali) is characterized by the acute onset of hypoxemia and noncardiogenic pulmonary edema within 6 hours of a blood or blood component transfusion in the absence of other causes of acute lung injury or circulatory overload.Various stimuli in blood components, most commonly white blood cell (wbc) antibodies from donors sensitized during pregnancy or prior transfusion or transplantation, or proinflammatory molecules that accumulate in stored blood components may cause trali.These mechanisms may not be mutually exclusive and may act synergistically with underlying patient factors to lead to a final common pathway of acute lung injury.These stimuli may trigger an inflammatory response, granulocyte activation and degranulation, and injury to the alveolar capillary membrane and the development of permeability pulmonary edema.Although most trali cases are associated with donor antileukocyte antibodies, rare cases have implicated recipient antileukocyte antibodies that reacted with donor leukocytes.Widespread leukoreduction of blood components has likely mitigated this latter risk.Laboratory testing of blood donors for antileukocyte antibodies or blood components for biological mediators does not alter management of this reaction, which is diagnosed on clinical and radiographic findings.Treatment of trali involves aggressive preferential use of plasma collected from male donors has been associated with a significant reduction in the number of reported trali cases and associated fatalities.According to the aabb circular of information for the use of human blood and blood components (revised 2017), allergic reactions frequently occur (ie, with 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually responds to antihistamines.More severe manifestations, including respiratory and cardiovascular symptoms, are more consistent with anayphylactoid/anaphylactic reactions and may require more aggressive therap.No laboratory procedures are available to predict these reactions.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.While these reactions have been reported in iga-deficient patients 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.According to the aabb circular of information for the use of human blood and blood components (revised 2017), transfusion-associated circulatory overload (taco) is a frequent complication of transfusion leading to cardiogenic (hydrostatic) pulmonary edema and can occur after transfusion of excessive volumes or at excessively rapid rates.This is a particular risk in individuals with underlying cardiopulmonary or renal disease, the very young and the elderly, and in patients with chronic severe anemia in who low red cells mass is associated with high plasma volume.Small transfusion volumes can precipitate symptoms in at-risk patients who already have a positive fluid balance.Pulmonary edema should promptly and aggressively treated, and infusion of colloid preparations, including plasma components and the supernatant fluid in cellular components, reduced to a minimum.According to the aabb circular of information for the use of human blood components (revised 2017), febrile nonhemolytic reactions are typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial.Since this is a study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021, the lot numbers were not provided; therefore, a disposable lot history search could not be conducted.As the covid-19 pandemic led to a national lockdown in norway on 12 march, 2020, we knew little about how this would affect the demand and availability of blood products.We anticipated that donor availability would decline but did not know whether blood demand would increase or decline as the pandemic progressed.In platelet concentrates (pcs), with a short shelf life of only seven days in norway, would be the first blood component affected by reduced collections or increased transfusions.To increase preparedness without increasing number of collections we decided to introduce cold stored platelets (csp) with 14-days shelf life for actively bleeding patients.This decision was based on results from previous laboratory and clinical studies performed by our department.1,2 in our laboratory study we found that in vitro assays measuring hemostasis and aggregation show csp on day 14 to be comparable to room temperature-stored platelets (rtp) on day 7.1 further, the results from our study of cold-stored platelet transfusions for patients with complex cardiothoracic surgery showed that csp is able to reduce and stop bleeding, also after storage for up to 14 days.2 our results are in accordance with several international laboratory studies, which have shown preserved platelet function during extended cold storage.1,3¿7 additionally, the risk of bacterial growth in csp is low and platelet aggregation response is better preserved in csp to rtp.From 17 march, 2020, the department of immunology and transfusion medicine at haukeland university hospital collected and produced csp units from apheresis (37% plasma/63% pas iiim, trima, terumo bct) from donors with blood type o or a.After two hours rest at room temperature, units for cold storage were labeled as cold-stored with 14 days shelf life.Quality control of the pcs was performed according to routine procedures.We aseptically removed samples for bacterial testing (bact/alert fa plus, bio-mérieux sa) on day 1 and incubated the samples for 13.5 days (bact/alert 3d, bio-mérieux sa).The csp units were stored under continuous temperature monitoring without agitation at 2°c¿6°c for a maximum of 14 days.Only pcs without aggregates were used and the units were stored cold from the day of collection.The majority of our apheresis pcs had aggregates after two hours rest.This often led to unnecessary donations of apheresis pc for cold storage when room temperature storage was sufficient.To simplify logistics without reducing quality or shelf life, we changed our procedure from 12 november 2020, to include pcs in which aggregates dissolved after agitation at room temperature to be transferred to cold storage one day after collection with 14 days shelf life.5,26 all patients receiving csp units were included in our patient quality registry.The following information was collected and registered in the database: age, gender, blood type, and ward for each patient, the indication for transfusion as well as blood usage and transfusion reactions for each transfusion episode, which was defined as 24 h following the first csp transfusion.Additionally, platelet count (plt) and hemoglobin (hbg) before and within 24 h after each transfusion episode were registered if analyzed.From 17 march, 2020, to 31 december, 2021, a total of 5147 pc units were produced of which 276 (5%) were csp units.In total, 186 csp units (3.6%) were transfused to 92 patients in 103 transfusion episodes (table 1).Median storage time of csp units at issue was six days (3¿9, 0¿14).Patient characteristics are described in table 1.The main indication for csp transfusion was surgical bleeding (figure 3).A total of 81 (88%) patients had surgical bleeding, and most of these patients underwent cardiovascular surgery.Csp units.The proportion of csp transfusions when compared to the total number of pc transfusions in the department of cardiovascular surgery also changed after this.During the 20 weeks leading up to the change in procedure, 14 of 134 pcs (10%) were csp while 31 of 173 (18%) were csp during the 20 weeks following the change.Only four of the 186 (2%) issued csp units were transfused to patients without bleeding.Two patients received csp in an emergency order or when admitted to the emergency ward but were not actively bleeding.The third patient, admitted to the postoperative thoracic surgery ward, received two prophylactic csp units before the procedure.None of these patients required immediate transfusions of additional platelets.Of the 92 patients, 86 (93%) received additional blood components and/or whole blood and 22 (24%) also received rtp units (table s1).All patients (100%) survived after one hour and 88 (96%) survived 24 h after the first transfusion.No deaths were associated with transfusion of csp units.Two of the patients who did not survive were on venous¿arterial extracorporeal membrane oxygenation (ecmo), one had post-operative complications after a fifth ileus operation and the fourth patient had an untreatable cancer diagnosis.No transfusion reactions were attributed to csp units.However, a young patient with postoperative bleeding developed transfusion-associated lung injury (trali) with symptoms starting after an emergency transfusion with two units of packed red cells.This patient underwent an emergency reoperation shortly after where he received additional transfusions of three units of packed red cells, two units of plasma, and one unit of csp.A postoperative chest radiography demonstrated bilateral opacities of the lungs.The attending anesthesiologist suspected trali which was confirmed by the immunohematology senior consultant.However, since silent hypoxia started before the transfusion of csp, they were not considered the cause of the transfusion reaction.During the study period, our department documented ten transfusion reactions to room temperature stored pcs, five mild allergic reactions, three transfusion associated circulatory overload (taco) reactions, one febrile reaction, and one anaphylactic reaction.For the patients with active bleeding there was a reduction in mean plt and hbg measured before and within 24 h after issue of the first csp unit (table 2).Teg 6s global hemostasis assay was ordered for a total of 30 patients, 18 before transfusion and 22 after transfusion (table s2).Results from the ten patients with analysis both before and after csp transfusions are displayed in table 3.The results show an improved hemostasis and aggregation ability after transfusion of csp.For these ten patients mean plt declined from 121 x 109/l (56, 187, 5¿280) to 115 x 109/l (75, 155, 5¿201) after transfusion of csp, while hgb increased from 9.2 g/dl (7.9, 10.6, 5.6¿11.8) to 9.4 g/dl (8.4, 10.4, 8.0¿13.1).Blood loss measured as chest drain output until 08:00 am the next morning was measured for the 65 patients who had thoracic drains post-operatively.There was a median blood loss of 800 ml (480¿1570, 180¿ 10,810).Plt declined similarly for these 65 patients from mean 187 x 109/l (168, 206, 31¿394) pre-operatively to 127 x 109/l (114, 140, 44¿290) post-operatively while hgb declined from 10.0 g/dl (9.4, 10.5, 5.6¿16.1) to 9.4 g/dl (9.1, 9.6, 7.6¿11.4).The patients in this quality database received transfusions due to active bleeding, where platelets are needed to form clots and thereby stop bleeding.Additionally, the majority of patients who underwent surgery are expected to have a fluid overload post-operatively compared to pre-operatively.This can explain the reduced plt and hgb at the end of the transfusion episode.Teg 6s global hemostasis assay is the only clinical measurement of hemostasis in the quality registry, and shows improved platelet aggregation despite a reduction in plt.This is consistent with laboratory studies finding csp to have better aggregation response compared to rtp.1,8¿10 the lack of reported transfusion reactions is in accordance with what we see for all types of blood components in patients undergoing surgery.It is not fully understood if there is a reduced risk of transfusion reactions during surgery or if there is an underreporting of events due to reactions being construed as a normal symptom post-operatively.Our previous clinical trial did not show any difference in transfusion reactions or thromboembolic events in the csp groups compared to the room temperature-stored platelets (rtp) group.2 a 24-h survival of 95.5% may at first glance seem low, however, all four patients that did not survive were high-risk patients where transfusion did not appear to affect the outcome.Discussion: csp with 14-days shelf life is a feasible alternative for the treatment of patients with bleeding.Implementation of a dual platelet inventory requires thorough planning, including information and training of clinical and laboratory staff, continuous follow-up of practice and patients, and an easy-to follow algorithm for use of csp units.A dual platelet inventory may mitigate the risk of platelet shortage during a pandemic situation.Root cause: a definitive root cause of the trali could not be determined.Possible reasons for trali include various stimuli in blood components, most commonly white blood cell (wbc) antibodies from donors sensitized during pregnancy or prior transfusion or transplantation or proinflammatory molecules that accumulate in stored blood components.These mechanisms may not be mutually exclusive and may act synergistically with underlying patient factors to lead to a final common pathway of acute lung injury.These stimuli may trigger an inflammatory response, granulocyte activation and degranulation, and injury to the alveolar capillary membrane and the development of permeability pulmonary edema.Although most trali cases are associated with donor antileukocyte antibodies, rare cases have implicated recipient antileukocyte antibodies that reacted with donor leukocytes.A definitive root cause of the allergic reactions could not be determined.Possible reasons for reactions related to transfusion of platelet concentrates include (i) ige and igg antibodies in the recipient against plasma proteins in the transfused blood component, (ii) transfusion of cytokines, chemokines, and histamine generated in the platelet product during preparation and storage.The best-known type of anaphylactic reaction is induced by iga deficiency of the recipient and subsequent formation of anti-iga.Patients lacking only one iga subclass may form subclass-specific anti-iga; other patients may get immunized against allotypes on the iga molecules.Patients with such antibodies of ¿limited specificity¿ usually experience less severe anaphylactic reactions than patients with complete iga deficiency and class-specific anti-iga.A definitive root cause of the taco could not be determined.Transfusion-associated circulatory overload (taco) is a frequent complication of transfusion leading to cardiogenic (hydrostatic) pulmonary edema and can occur after transfusion of excessive volumes or at excessively rapid rates.This is a particular risk in individuals with underlying cardiopulmonary or renal disease, the very young and the elderly, and in patients with chronic severe anemia in who low red cells mass is associated with high plasma volume.Small transfusion volumes can precipitate symptoms in at-risk patients who already have a positive fluid balance.A root cause assessment was performed for the febrile non-hemolytic transfusion reaction.The reported adverse events are common side effects of transfusion.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * the action of antibodies against white cells or the action of cytokines either present in the transfused component or generated by the recipient in response to transfused elements.* patients received non-leukocyte-reduced cohgbmponents.* patients were previously alloimunized by transfusion or pregnancy.A root cause assessment was performed for the reduction in platelet count and hemoglobin.According to the authors, "the patients in this quality database received transfusions due to active bleeding, where platelets are needed to form clots and thereby stop bleeding.Additionally, the majority of patients who underwent surgery are expected to have a fluid overload post-operatively compared to pre-operatively.This can explain the reduced plt and hgb at the end of the transfusion episode.".
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Event Description
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The article, "implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored apheresis platelets for treatment of actively bleeding patients", describes a study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021.A total of 276 cold-stored apheresis platelets (csp) units was produced and 186 units were transfused to 92 patients.During the study period, their department documented ten transfusion reactions to room temperature stored pcs, five mild allergic reactions, three transfusion associated circulatory overload (taco) reactions, one febrile reaction, and one anaphylactic reaction.For the patients with active bleeding there was a reduction in mean plt and hbg measured before and within 24 h after issue of the first csp unit (table 2).For these ten patients mean plt declined from 121 x 109/l (56, 187, 5¿280) to 115 x 109/l (75, 155, 5¿201) after transfusion of csp, while hgb increased from 9.2 g/dl (7.9, 10.6, 5.6¿11.8) to 9.4 g/dl (8.4, 10.4, 8.0¿13.1).Blood loss measured as chest drain output until 08:00 am the next morning was measured for the 65 patients who had thoracic drains post-operatively.There was a median blood loss of 800 ml (480¿1570, 180¿ 10,810).Plt declined similarly for these 65 patients from mean 187 x 109/l (168, 206, 31¿394) pre-operatively to 127 x 109/l (114, 140, 44¿290) post-operatively while hgb declined from 10.0 g/dl (9.4, 10.5, 5.6¿16.1) to 9.4 g/dl (9.1, 9.6, 7.6¿11.4).This is a study which evaluated the implementation of a dual platelet inventory in a tertiary hospital during the covid-19 pandemic enabling cold-stored platelets (37% plasma/63% pas iiim, trima, terumo bct) for treatment of actively bleeding patients from 17 march, 2020, to 31 december, 2021.A request for specific donor information is not feasible.The disposable sets are not available for return from the customer.
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Search Alerts/Recalls
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