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| Model Number 82446 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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| Patient Problems
Erythema (1840); Respiratory Failure (2484)
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| Event Date 05/01/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Lot number, manufacture date and expiry date are not available at this time.Investigation: per the abstract: "background: the pathogen reduction technologies (prts) for blood components enhance the blood safety by minimizing the risks of transfusion transmitted infection, the transfusion¿related adverse events (traes) and increase the life duration of p-pcs.Currently, we are confronted with a pandemic disease, the covid-19, caused by the sars-cov-2 virus, which is characterized by high morbidity and mortality and limited therapeutic approaches.The convalescent plasma (cp), containing antibodies for sars-cov-2 virus is one of these options with therapeutic efficacy although the pi of cp is not mandatory the isbt recommends prts as "high desirable".Aims: our aim was to present our experience and data of the pathogen reduction technology of intercept (cerus) blood system (ibs) regarding the technique, the application and the quality of the treated products in our institute as well as the traes to the recipients.Methods: the covid-19 cps were collected by apheresis using terumo bct trima accel collection system version 6_0.25 cp collections from 22 donors, who fulfilled the criteria of ecdc for covid-19 cp donors, were performed.The volume of each cp after apheresis was 600 to 800 ml.Ibs was used as pi method.Afterwards, the cps were split in doses of 200 ml and were stored in freezer at -80c until administration.For pi treatment applied in 10% of the annual production of p-pcs, displacing the ionizing irradiation.In a 9 months period, 100 p-pcs from 4 or 5 buffy coats were treated.For pi treatment each unit of p-pc had to fulfill the following criteria: additive solution (pas) / plasma ratio: 65/35 (%), plt yield > 2,5x 1011, rbc's concentration < 4x106 / ul, volume: 300-420 ml.Quality control was conducted on every treated component and they were transfused to haematological patients aged between 17 and 60 years old, with good life expectancy.Summary/conclusions: the application of ibs in covid-19 cps and p-pcs is simple and can be easily introduced in a regional institute.In addition, adequate platelet and plasma doses were performed after pi processing and no significant adverse events were observed to the recipients.While the pi implementation will result in additional costs we believe that the method is worth applying as it enhances transfusion safety, especially in frail covid-19 cp recipients." citation: papadogiannaki m et al.The greek experience of pathogen-reduced covid-19 convalescent plasma and pooled-platelet concentrates (p-pcs) using the intercept pathogen inactivation (pi) system.Vox sanguinis.2021.P-241.Refid: 101 (papadogiannaki et al 2021) investigation is in process.A follow-up report will be provided.
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Event Description
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A conference abstract "the greek experience of pathogen-reduced covid-19 convalescent plasma and pooled-platelet concentrates (p-pcs) using the intercept pathogen inactivation (pi) system" by papadogiannaki m et al presented a study that described data on pathogen reduction technology for covid-19 convalescent plasma and pooled-platelet concentrates.Covid-19 convalescent plasma was collected using trima accel from 22 donors.The convalescent plasma was treated with the intercept blood system then was transfused to haematological patients (ages 17-60 years).Forty-six of the inactivated convalescent plasma were transfused to patients.One adverse event occurred; ¿erythema and exacerbation of respiratory failure was observed 2 hours after transfusion.¿ in addition, 100 pooled-platelet concentrates were treated.No adverse events occurred in patients transfused with treated pooled-platelet concentrates.Results: the ibs was easily applied in the daily routine of our department and the staff¿s training was simple and fast.All plasma collections were performed without adverse events to the donors.Pi treatment was performed in the 60/93 plasma products.Thirty-eight of the inactivated cps were transfused to the patients at the covid department (cd) and 8 to the patients at the icu.In one covid-19 cp recipient, an adverse event characterized by erythema and exacerbation of respiratory failure was observed 2 hours after transfusion.The patient was admitted in the icu for 24 hours and he was treated as transfusion¿related acute lung injury (trali).As the cp was donated from a male donor with no history of transfusions and negative anti-hla and anti-granulocyte testing the trali syndrome was not demonstrated.With regard to p-pcs the mean plt yield per product was 3.17 (+/-0.58) 1011 while the loss of plt in processing was 8% (+/-0.4%).All pi treated p-pcs were transfused to the group of patients that was scheduled and no traes were observed.Patient id, age, weight and outcome are not available at this time.The disposables set is not available for return because it was discarded by the customer.
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Event Description
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A conference abstract "the greek experience of pathogen-reduced covid-19 convalescent plasma and pooled-platelet concentrates (p-pcs) using the intercept pathogen inactivation (pi) system" by papadogiannaki m et al presented a study that described data on pathogen reduction technology for covid-19 convalescent plasma and pooled-platelet concentrates.Covid-19 convalescent plasma was collected using trima accel from 22 donors.The convalescent plasma was treated with the intercept blood system then was transfused to haematological patients (ages 17-60 years).Forty-six of the inactivated convalescent plasma were transfused to patients.One adverse event occurred; ¿erythema and exacerbation of respiratory failure was observed 2 hours after transfusion.¿ in addition, 100 pooled-platelet concentrates were treated.No adverse events occurred in patients transfused with treated pooled-platelet concentrates.Results: the ibs was easily applied in the daily routine of our department and the staff¿s training was simple and fast.All plasma collections were performed without adverse events to the donors.Pi treatment was performed in the 60/93 plasma products.Thirty-eight of the inactivated cps were transfused to the patients at the covid department (cd) and 8 to the patients at the icu.In one covid-19 cp recipient, an adverse event characterized by erythema and exacerbation of respiratory failure was observed 2 hours after transfusion.The patient was admitted in the icu for 24 hours and he was treated as transfusion¿related acute lung injury (trali).As the cp was donated from a male donor with no history of transfusions and negative anti-hla and anti-granulocyte testing the trali syndrome was not demonstrated.With regard to p-pcs the mean plt yield per product was 3.17 (+/-0.58) 1011 while the loss of plt in processing was 8% (+/-0.4%).All pi treated p-pcs were transfused to the group of patients that was scheduled and no traes were observed.Patient id, age, weight and outcome are not available at this time.The disposables set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in e.1 and h.10.Investigation: per the abstract: "background: the pathogen reduction technologies (prts) for blood components enhance the blood safety by minimizing the risks of transfusion transmitted infection, the transfusion¿related adverse events (traes) and increase the life duration of p-pcs.Currently, we are confronted with a pandemic disease, the covid-19, caused by the sars-cov-2 virus, which is characterized by high morbidity and mortality and limited therapeutic approaches.The convalescent plasma (cp), containing antibodies for sars-cov-2 virus is one of these options with therapeutic efficacy although the pi of cp is not mandatory the isbt recommends prts as "high desirable".Aims: our aim was to present our experience and data of the pathogen reduction technology of intercept (cerus) blood system (ibs) regarding the technique, the application and the quality of the treated products in our institute as well as the traes to the recipients.Methods: the covid-19 cps were collected by apheresis using terumo bct trima accel collection system version 6_0.25 cp collections from 22 donors, who fulfilled the criteria of ecdc for covid-19 cp donors, were performed.The volume of each cp after apheresis was 600 to 800 ml.Ibs was used as pi method.Afterwards, the cps were split in doses of 200 ml and were stored in freezer at -80c until administration.For pi treatment applied in 10% of the annual production of p-pcs, displacing the ionizing irradiation.In a 9 months period, 100 p-pcs from 4 or 5 buffy coats were treated.For pi treatment each unit of p-pc had to fulfill the following criteria: 1.Additive solution (pas) / plasma ratio: 65/35 (%), 2.Plt yield > 2,5x 1011, 3.Rbc's concentration < 4x106 / ul, 4.Volume: 300-420 ml.Quality control was conducted on every treated component and they were transfused to haematological patients aged between 17 and 60 years old, with good life expectancy.Summary/conclusions: the application of ibs in covid-19 cps and p-pcs is simple and can be easily introduced in a regional institute.In addition, adequate platelet and plasma doses were performed after pi processing and no significant adverse events were observed to the recipients.While the pi implementation will result in additional costs we believe that the method is worth applying as it enhances transfusion safety, especially in frail covid-19 cp recipients." citation: papadogiannaki m et al.The greek experience of pathogen-reduced covid-19 convalescent plasma and pooled-platelet concentrates (p-pcs) using the intercept pathogen inactivation (pi) system.Vox sanguinis.2021.P-241.Refid: 101 (papadogiannaki et al 2021) 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 respiratory support, and often mechanical ventilation.The 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.This was an abstract to present a study that described data on pathogen reduction technology for covid-19 convalescent plasma and pooled-platelet concentrates.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.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 additional information in b.5, h.6 and h.10.Investigation: per the abstract: "background: the pathogen reduction technologies (prts) for blood components enhance the blood safety by minimizing the risks of transfusion transmitted infection, the transfusion¿related adverse events (traes) and increase the life duration of p-pcs.Currently, we are confronted with a pandemic disease, the covid-19, caused by the sars-cov-2 virus, which is characterized by high morbidity and mortality and limited therapeutic approaches.The convalescent plasma (cp), containing antibodies for sars-cov-2 virus is one of these options with therapeutic efficacy although the pi of cp is not mandatory the isbt recommends prts as "high desirable".Aims: our aim was to present our experience and data of the pathogen reduction technology of intercept (cerus) blood system (ibs) regarding the technique, the application and the quality of the treated products in our institute as well as the traes to the recipients.Methods: the covid-19 cps were collected by apheresis using terumo bct trima accel collection system version 6_0.25 cp collections from (b)(4) donors, who fulfilled the criteria of ecdc for covid-19 cp donors, were performed.The volume of each cp after apheresis was 600 to 800 ml.Ibs was used as pi method.Afterwards, the cps were split in doses of 200 ml and were stored in freezer at -80c until administration.For pi treatment applied in (b)(4) of the annual production of p-pcs, displacing the ionizing irradiation.In a 9 months period, (b)(4) pcs from 4 or 5 buffy coats were treated.For pi treatment each unit of p-pc had to fulfill the following criteria: 1.Additive solution (pas) / plasma ratio: (b)(4)), 2.Plt yield > (b)(4), 3.Rbc's concentration < 4x106 / ul, 4.Volume: 300-420 ml.Quality control was conducted on every treated component and they were transfused to haematological patients aged between 17 and 60 years old, with good life expectancy.Summary/conclusions: the application of ibs in covid-19 cps and p-pcs is simple and can be easily introduced in a regional institute.In addition, adequate platelet and plasma doses were performed after pi processing and no significant adverse events were observed to the recipients.While the pi implementation will result in additional costs we believe that the method is worth applying as it enhances transfusion safety, especially in frail covid-19 cp recipients." citation: papadogiannaki m et al.The greek experience of pathogen-reduced covid-19 convalescent plasma and pooled-platelet concentrates (p-pcs) using the intercept pathogen inactivation (pi) system.Vox sanguinis.2021.P-241.Refid: 101 (papadogiannaki et al 2021) 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 respiratory support, and often mechanical ventilation.The 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.This was an abstract to present a study that described data on pathogen reduction technology for covid-19 convalescent plasma and pooled-platelet concentrates.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.No additional details are available regarding the extent of medical intervention required by the donor.According to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about (b)(4) of donations.Reactions that need medical care after the donor has left the donation site are seen in (b)(4) donors.The patient was admitted in the icu for 24 hours and he was treated as transfusion¿related acute lung injury (trali).As the cp was donated from a male donor with no history of transfusions and negative anti-hla and anti-granulocyte testing the trali syndrome was not demonstrated.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for the donor's adverse reactions could not be determined.Possible root causes include but are not limited to the donor's physiology, lingering symptoms of prior covid infection, and/or sensitivity to the procedure.
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Event Description
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A conference abstract "the greek experience of pathogen-reduced covid-19 convalescent plasma and pooled-platelet concentrates (p-pcs) using the intercept pathogen inactivation (pi) system" by papadogiannaki m et al presented a study that described data on pathogen reduction technology for covid-19 convalescent plasma and pooled-platelet concentrates.Covid-19 convalescent plasma was collected using trima accel from (b)(4) donors.The convalescent plasma was treated with the intercept blood system then was transfused to haematological patients (ages 17-60 years).Forty-six of the inactivated convalescent plasma were transfused to patients.One adverse event occurred; ¿erythema and exacerbation of respiratory failure was observed 2 hours after transfusion.¿ in addition, 100 pooled-platelet concentrates were treated.No adverse events occurred in patients transfused with treated pooled-platelet concentrates.Results: the ibs was easily applied in the daily routine of our department and the staff¿s training was simple and fast.All plasma collections were performed without adverse events to the donors.Pi treatment was performed in the (b)(4) plasma products.(b)(4) of the inactivated cps were transfused to the patients at the covid department (cd) and (b)(4) to the patients at the icu.In one covid-19 cp recipient, an adverse event characterized by erythema and exacerbation of respiratory failure was observed 2 hours after transfusion.The patient was admitted in the icu for 24 hours and he was treated as transfusion¿related acute lung injury (trali).As the cp was donated from a male donor with no history of transfusions and negative anti-hla and anti-granulocyte testing the trali syndrome was not demonstrated.With regard to p-pcs the mean plt yield per product was (b)(4) while the loss of plt in processing was (b)(4).All pi treated p-pcs were transfused to the group of patients that was scheduled and no traes were observed.Due to eu personal data protection laws, the patient information is not available from the customer.The disposables set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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