| Catalog Number |
80400 |
| Medical Device Problem Codes |
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
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| Health Effect - Clinical Codes |
Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Anxiety (2328); Loss of consciousness (2418)
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| Date of Event |
08/17/2020
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Das, s.S., sen, s., zaman, r.U., & biswas, r.N.(2020).Plateletpheresis in the era of automation: optimizing donor safety and product quality using modern apheresis instruments.Indian journal of hematology and blood transfusion, 37(1), 134¿139.Https://doi.Org/10.1007/s12288-020-01337-1.
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Event or Problem Description
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Per journal article "plateletpheresis in the era of automation: optimizing donor safety and product quality using modern apheresis instruments".By das, s.S., sen, s., zaman, r.U., biswas, r.N.Abstract: the increases in major surgeries, transplantations and speciality clinics have significantly increased the utilization of platelet concentrates including single donor platelets (sdp).The advantages of sdp or apheresis platelet have been discussed elaborately by previous authors as compared to random donor platelets.Here we share our experiences of plateletpheresis procedures using the modern apheresis machines with regards to product quality and donor safety.This study included 3016 procedures of plateletpheresis (1397 on amicus and 1619 on trima accel cell separators) on eligible donors using recommended apheresis kits.A target yield of 3 9 1011 was set as the end point of each procedure.Donor details, procedure details and donor adverse reactions if any were documented.Statistical analysis was done using the spss statistical package (version 13, usa).Of the total 6276 donors screened 2049 (32.6%) were deferred due to various reasons.Out of remaining 4227 eligible donors; 3016 (71.4%) underwent plateletphereis procedures based on the requirement of sdp by the patients.Mean pre-procedure platelet count and hematocrit in donors were 188.3 9 106 / ml and 41.7% respectively.Mean procedure time in amicus (76.6 min) was significantly more than the trima accel (64.3 min) (p = 0.02).Platelet yield by trima accel and amicus was 2.96 9 1011 and 3.08 9 1011 respectively (p = 0.061).A total of 40 donors (1.33%) suffered adverse effect during or after apheresis procedures.While the modern plateletpheresis devices are both donor and user friendly at the same time they provide quality product consistently in lesser time.The collection set is not available for return because it was discarded by the customer.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events.
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Event or Problem Description
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Per journal article "plateletpheresis in the era of automation: optimizing donor safety and product quality using modern apheresis instruments".By das, s.S., sen, s., zaman, r.U., biswas, r.N.Abstract: the increases in major surgeries, transplantations and speciality clinics have significantly increased the utilization of platelet concentrates including single donor platelets (sdp).The advantages of sdp or apheresis platelet have been discussed elaborately by previous authors as compared to random donor platelets.Here we share our experiences of plateletpheresis procedures using the modern apheresis machines with regards to product quality and donor safety.This study included 3016 procedures of plateletpheresis (1397 on amicus and 1619 on trima accel cell separators) on eligible donors using recommended apheresis kits.A target yield of 3 9 1011 was set as the end point of each procedure.Donor details, procedure details and donor adverse reactions if any were documented.Statistical analysis was done using the spss statistical package (version 13, usa).Of the total 6276 donors screened 2049 (32.6%) were deferred due to various reasons.Out of remaining 4227 eligible donors; 3016 (71.4%) underwent plateletphereis procedures based on the requirement of sdp by the patients.Mean pre-procedure platelet count and hematocrit in donors were 188.3 9 106 / ml and 41.7% respectively.Mean procedure time in amicus (76.6 min) was significantly more than the trima accel (64.3 min) (p = 0.02).Platelet yield by trima accel and amicus was 2.96 9 1011 and 3.08 9 1011 respectively (p = 0.061).A total of 40 donors (1.33%) suffered adverse effect during or after apheresis procedures.While the modern plateletpheresis devices are both donor and user-friendly at the same time they provide quality product consistently in lesser time.The collection set is not available for return because it was discarded by the customer.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events.
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Additional Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.11.Investigation: since this was a journal publication outlining a retrospective study including 3016 procedures of plateletpheresis from january 2013 to june 2019, the disposable lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Since this was a journal publication outlining a retrospective study including 3016 procedures of plateletpheresis from january 2013 to june 2019, the disposable lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release summary of terumo bct product in relation to the journal article: the advantages of apheresis platelet or single donor platelet (sdp) have been discussed by previous authors extensively.With the increase of specialty clinics like oncology, clinical hematology, critical care medicine, hepatology and transplants the use of platelet concentrates have increased in the recent past.Unlike platelet concentrates prepared from whole blood also known as random donor platelets (rdp), sdps are associated with lower transfusion transmitted infections, alloimmunization, platelet refractoriness and other transfusion related adverse events.There has been an increasing trend towards the use of sdp to support thrombocytopenic patients.Collection of sdp by apheresis procedure also known as plateletpheresis is usually safe without serious complications to the donors.Here the authors share their experience of plateletpheresis or collections of sdp using latest apheresis machines and discuss their observation on donor safety and platelet quality with regards to platelet yield and leukodepletion.This retrospective study included 3016 procedures of plateletpheresis from january 2013 to june 2019.All procedures were performed on eligible donors taking informed consent as per laws enacted in the drugs and cosmetic acts (dca), india.All procedures were performed by the same apheresis team.Following registration all donors were screened for age, weight, blood group, medical history, drug history, vein status and other selection criteria mandated by the dca.For donors who qualified in the initial screening test, whole blood samples were collected for mandatory laboratory screening as per national guidelines for plateletpheresis.Whole blood (wb) samples in edta and clotted vials were collected before plateletpheresis procedure.Hematological parameters such as platelets (plt), hemoglobin (hb), hematocrit (hct), wbc count were measured using a calibrated automated cell counter (icount 3cp, iris healthcare technologies private limited, india).Blood group and antibody screening were confirmed followed by testing for infectious markers.Only those donors who were qualified in the screening test were selected for plateletpheresis procedure.All plateletpheresis procedures were performed following manufacturer¿¿¿s instructions and departmental standard operating procedure (sop) using recommended apheresis kits.The end point of each procedure was based on the target yield of 3 x 1011 platelets per unit.Donor details like name, registration number, blood group, age, gender, weight, hematological values and plateletpheresis procedure details, such as kit details, total blood volume processed, anticoagulant (acid-citrate-dexrose -a, acd-a) volume used, procedure time, blood flow rate and collection efficiency of machines (plt yield/total plt processed x 100) were recorded for each procedure in the procedure register.All donors were administered prophylactic oral calcium (1000 mg) and they were explained the details of procedure before starting it.They were advised to report discomfort if any to the apheresis team during or after the procedure.They were asked to take adequate rest after the procedure and leave the aphresis centre after obtaining permission from the apheresis team.Donor adverse reactions if any were managed appropriately and documented following departmental sop.Vasovagal adverse reactions were classified into three categories of severity: mild grade (grade i) for presyncopal vasovagal reactions such as pallor, sweating, anxiety; moderate grade (grade ii) for hypotension, vomiting, and transient loss of consciousness; and severe grade (grade iii) for loss of consciousness associated with other signs and symptoms such as recurrent vomiting, prolonged pulse and/or blood pressure recovery times, incontinence and convulsions.1.Amicus cell separator, (version 3.21, fresenius kabi ag, bad homburg, germany): 1397.2.Trima accel cell separator (version 5.1, terumo bct, lakewood, usa): n = 1619.Approximately 1 ml sample from each bag was collected in edta vial after thoroughly stripping the segment to ensure a representative product of the bag.All samples were mixed thoroughly and subjected to measurements of quality parameters such as volume, ph, hct, plt, rbc and wbc counts [1316].The ph of all platelet units were measured by a calibrated portable ph meter (eutech instruments, thermo fisher scientific, singapore) following manufacturers instruction.Residual wbc content of the bag was measured by nageotte chamber hemocytometer counts.Swirling in platelet units was assessed visually and documented as present or absent.Of the total 6276 donors screened during the study period 2049 (32.6%) were deferred due to various reasons.The primary causes of overall deferral were poor venous access (32.2%), low hemoglobin (29.6%) and low platelet count (26.9%).Mean pre-procedure platelet count and hematocrit were 188.3 x 106/ml and 41.7% respectively.Mean anticoagulant use in trima accel and amicus was 309.3 ml and 319.4 ml respectively with no statistical significance (p = 0.08).Mean procedure time in amicus (79.6 min) was significantly more than the trima accel (64.3 min) (p = 0.02).Mean collection efficiency of both cell separators was comparable.Quality of platelet product obtained from both machines was comparable with parameter values within recommended range.The mean volume of product processed by trima accel was 217.4 ml and amicus was 223.8 ml.Platelet yield by trima accel and amicus was 2.96 x 1011 (range: 2.72, 3.15) and 3.08 x 1011 (range: 2.87,3.31) respectively (p = 0.061).A total of 31(2.2%) and 42 (2.6%) sdp collected by amicus and trima accel respectively could not met the target yield of 3 x 1011 platelets per unit as described in the indian national standards plateletpheresis associated citrate toxicity was higher with the amicus (11 vs.9) and vasovagal side effects was observed more with trima accel (7 vs.4).A total of 40 donors (1.33%) suffered adverse effect during or after apheresis procedures.Regarding terumo bct product, trima accel, a total of 21 out of 1619 procedures encountered adverse reactions, 9 of those were in relation to citrate toxicity, 5 were due to hematoma formation and 7 were vasovagal.Of the 7 vasovagal reactions, there were 0 severe (grade iii) reactions, 1 moderate grade (grade ii) reaction and 6 mild (grade i) reactions.Early recognition of adverse events related to plateletpheresis and thereby preventing their occurrences is important to encourage donor retention [36].Donor adverse events like citrate toxicity, hematoma and vasovagal reactions were observed in 40 donors (1.33%) and were comparable in both the machines.Despite administering prophylactic oral calcium (1000 mg) as suggested by previous authors citrate toxicity was found in 20 out of the 40 affected donors in the present study.It was observed that 20% of procedures performed with prophylactic calcium were associated with symptoms, most of which were mild [38].The various reasons for these symptoms may include (a) donors who undergo the procedure repeatedly or for prolonged periods are susceptible to an accumulation of excess citrate leading to inappropriate metabolism by the body.(b) hypocalcaemia like symptoms may be caused by hypomagnesaemia and calcium supplementation becomes unfruitful, (c) apheresis procedures in donors with low normal platelet count take more time to achieve the target yield and result in higher infusion of acd, (d) symptoms may be due to suboptimal dose of prophylactic oral calcium because it has been observed that administration of 2000 mg of calcium carbonate was associated with a statistically significant reduction in the severity of paresthesia [38, 43], (e) we also predict that calcium dose and its time of administration play role in counter acting the effect of citrate metabolism.Both machines used in the present study consistently provided optimized platelet products irrespective of their variations in inherent working programs.Mean procedure time was significantly higher in amicus (79.6 min) than trima (64.3 min) (p = 0.02).As procedure time directly concerns the apheresis donors therefore it is an important parameter to evaluate the safety and comfort of healthy donors.Both machines exhibited comparable collection efficiency and acd utilization.Though significant ce variation was not observed in the present study (67.3% vs.66.1%) but ce is said to be greatly affected by platelet yield and post-procedure platelet which in turn depend on the donor population.The mean volume of final product was higher in the amicus compared trima accel but the difference was not significant.(p = 0.11).Mean yield of platelets in the final product, which is the most important quality parameter, was found to be comparable in both the machines (p = 0.061).In the present study 97.6% of the platelet product could achieve the target platelet yield of 3 x 1011 against the recommended 75% or 90% published by national and international authorities respectively.In the present study the mean residual leukocyte content was observed to be 1.3 x 106 and 1.6 x 106 per sdp unit by trima accel and amicus respectively and all products complied with the aabb criteria of 5 x 106 leukocytes per unit the authors concluded that plateletpheresis using new generation automated cell separators have significantly optimized quality of sdp in terms of platelet yield, leukodepletion and red cell contamination in comparison to their older versions.Moreover an increase in collection efficiency, lesser whole blood processing, reduced procedure time and low utilization of anticoagulants greatly enhanced donor safety thereby ensuring donor retention, bigger voluntary donor pool and repeat donations.Further to prevent citrate related toxicity and recommendation by previous workers; apheresis centres may administer prophylactic oral calcium to donors in a dose of 1000,2000 mg at least 30 min prior to the procedure.In relation to the lower-than-expected yield, based on existing internal risk assessments which incorporate risk to patients or donors compared to occurrence rates, this failure does not have a high risk.A risk assessment was conducted for the adverse events outlined in this study.According to the aabb technical manual, adverse reactions can occur at the time of donation or after the donor has left the blood center.In a comprehensive donor hemovigilance program reported by the american red cross, adverse reactions were reported for wb collections (349 in 10,000), plateletpheresis (578 in 10,000), and double rbc unit collections (538 in 10,000), the vast majority of which were minor presyncopal reactions and small hematomas.According to the aabb technical manual: vasovagal reactions (also referred to as pre-faint or presyncope) include dizziness, sweating, nausea, vomiting, weakness, apprehension, pallor, hypotension, and bradycardia.The reaction might progress to syncope (loss of consciousness); convulsions and loss of bladder and bowel function might also occur.Syncope can also result from orthostatic blood pressure changes after donation.Vasovagal reactions are distinguished by a low pulse rate, whereas reactions related to volume depletion are associated with an increased pulse rate.This difference, however, has no practical value, as both mechanisms are treated similarly.In case of vasovagal reaction, phlebotomy should be stopped, and the donor should be placed in a recumbent position blood systems, inc, reported a rate of syncope during and after phlebotomy as 27 per 10,000 wb donations, with an associated injury rate of 1.3 per 10,000 wb donations.Approximately 10% of loss of consciousness reactions occur after the donor leaves the donation site.According to the aabb technical manual: citrate reactions: during apheresis, blood that is anticoagulated with citrate in the apheresis systems is returned to the donor at an acceptable rate.In healthy individuals, citrate is rapidly metabolized, but some donors can experience mild citrate reactions (paresthesias or tingling sensations).Oral calcium supplementation is advised for symptomatic management of hypocalcemia (see attachment, aabb technical manual pg 144 in content tab).Hypocalcemia has been noted with rapid transfusions.This is usually transient and dependent on the amount and rate of citrate infused.Calcium replacement may be administered based on the recipients ionized serum calcium level and the rate of citrate administration.Venous access devices may cause thrombosis.Infrequently, their placement may result in severe complications, such as pneumothorax, arrhythmia, or perforation of the heart or great vessels, occurring with up to 1% of procedures.Other complications such as arterial puncture, deep hematomas, and av formation are more frequent, occurring with 1% to 3% of procedures.(see attachment, aabb technical manual pg 710 in content tab).With further reference to needle-related injuries (such as a bruise or hematoma); bruises are the most common adverse event after phlebotomy, occurring in 23% of donors based on postdonation interviews.Hematomas, defined as the accumulation of blood under the skin, are less common than bruises, occurring in 1.7% of donors.Bruises and minor hematomas (less than 2 by 2inches) generally do not prevent donors from donating again.Investigation is in process; a follow-up report will be provided.Citation: das, s.S., sen, s., zaman, r.U., & biswas, r.N.(2020).Plateletpheresis in the era of automation: optimizing donor safety and product quality using modern apheresis instruments.Indian journal of hematology and blood transfusion, 37(1), 134139.Https://doi.Org/10.1007/s12288-020-01337-1.
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Additional Manufacturer Narrative
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This report is being filed to provide additional information in b.2, b.5, h.6 and h.11.Investigation: since this was a journal publication outlining a retrospective study including 3016 procedures of plateletpheresis from january 2013 to june 2019, the disposable lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release summary of terumo bct product in relation to the journal article: the advantages of apheresis platelet or single donor platelet (sdp) have been discussed by previous authors extensively.With the increase of specialty clinics like oncology, clinical hematology, critical care medicine, hepatology and transplants the use of platelet concentrates have increased in the recent past.Unlike platelet concentrates prepared from whole blood also known as random donor platelets (rdp), sdps are associated with lower transfusion transmitted infections, alloimmunization, platelet refractoriness and other transfusion related adverse events.There has been an increasing trend towards the use of sdp to support thrombocytopenic patients.Collection of sdp by apheresis procedure also known as plateletpheresis is usually safe without serious complications to the donors.Here the authors share their experience of plateletpheresis or collections of sdp using latest apheresis machines and discuss their observation on donor safety and platelet quality with regards to platelet yield and leukodepletion.This retrospective study included 3016 procedures of plateletpheresis from january 2013 to june 2019.All procedures were performed on eligible donors taking informed consent as per laws enacted in the drugs and cosmetic acts (dca), india.All procedures were performed by the same apheresis team.Following registration all donors were screened for age, weight, blood group, medical history, drug history, vein status and other selection criteria mandated by the dca.For donors who qualified in the initial screening test, whole blood samples were collected for mandatory laboratory screening as per national guidelines for plateletpheresis.Whole blood (wb) samples in edta and clotted vials were collected before plateletpheresis procedure.Hematological parameters such as platelets (plt), hemoglobin (hb), hematocrit (hct), wbc count were measured using a calibrated automated cell counter (icount 3cp, iris healthcare technologies private limited, india).Blood group and antibody screening were confirmed followed by testing for infectious markers.Only those donors who were qualified in the screening test were selected for plateletpheresis procedure.All plateletpheresis procedures were performed following manufacturer¿s instructions and departmental standard operating procedure (sop) using recommended apheresis kits.The end point of each procedure was based on the target yield of 3 x 1011 platelets per unit.Donor details like name, registration number, blood group, age, gender, weight, hematological values and plateletpheresis procedure details, such as kit details, total blood volume processed, anticoagulant (acid-citrate-dexrose -a, acd-a) volume used, procedure time, blood flow rate and collection efficiency of machines (plt yield/total plt processed x 100) were recorded for each procedure in the procedure register.All donors were administered prophylactic oral calcium (1000 mg) and they were explained the details of procedure before starting it.They were advised to report discomfort if any to the apheresis team during or after the procedure.They were asked to take adequate rest after the procedure and leave the aphresis centre after obtaining permission from the apheresis team.Donor adverse reactions if any were managed appropriately and documented following departmental sop.Vasovagal adverse reactions were classified into three categories of severity: mild grade (grade i) for presyncopal vasovagal reactions such as pallor, sweating, anxiety; moderate grade (grade ii) for hypotension, vomiting, and transient loss of consciousness; and severe grade (grade iii) for loss of consciousness associated with other signs and symptoms such as recurrent vomiting, prolonged pulse and/or blood pressure recovery times, incontinence and convulsions.1.Amicus cell separator, (version 3.21, fresenius kabi ag, bad homburg, germany): 1397.2.Trima accel cell separator (version 5.1, terumo bct, lakewood, usa): n = 1619.Approximately 1 ml sample from each bag was collected in edta vial after thoroughly stripping the segment to ensure a representative product of the bag.All samples were mixed thoroughly and subjected to measurements of quality parameters such as volume, ph, hct, plt, rbc and wbc counts [13¿16].The ph of all platelet units were measured by a calibrated portable ph meter (eutech instruments, thermo fisher scientific, singapore) following manufacturer¿s instruction.Residual wbc content of the bag was measured by nageotte chamber hemocytometer counts.Swirling in platelet units was assessed visually and documented as ¿present¿ or ¿absent¿.Of the total 6276 donors screened during the study period 2049 (32.6%) were deferred due to various reasons.The primary causes of overall deferral were poor venous access (32.2%), low hemoglobin (29.6%) and low platelet count (26.9%).Mean pre-procedure platelet count and hematocrit were 188.3 x 106/ml and 41.7% respectively.Mean anticoagulant use in trima accel and amicus was 309.3 ml and 319.4 ml respectively with no statistical significance (p = 0.08).Mean procedure time in amicus (79.6 min) was significantly more than the trima accel (64.3 min) (p = 0.02).Mean collection efficiency of both cell separators was comparable.Quality of platelet product obtained from both machines was comparable with parameter values within recommended range.The mean volume of product processed by trima accel was 217.4 ml and amicus was 223.8 ml.Platelet yield by trima accel and amicus was 2.96 x 1011 (range: 2.72 ¿ 3.15) and 3.08 x 1011 (range: 2.87¿3.31) respectively (p = 0.061).A total of 31(2.2%) and 42 (2.6%) sdp collected by amicus and trima accel respectively could not met the target yield of = 3 x 1011 platelets per unit as described in the indian national standards plateletpheresis associated citrate toxicity was higher with the amicus (11 vs.9) and vasovagal side effects was observed more with trima accel (7 vs.4).A total of 40 donors (1.33%) suffered adverse effect during or after apheresis procedures.Regarding terumo bct product, trima accel, a total of 21 out of 1619 procedures encountered adverse reactions, 9 of those were in relation to citrate toxicity, 5 were due to hematoma formation and 7 were vasovagal.Of the 7 vasovagal reactions, there were 0 severe (grade iii) reactions, 1 moderate grade (grade ii) reaction and 6 mild (grade i) reactions.Early recognition of adverse events related to plateletpheresis and thereby preventing their occurrences is important to encourage donor retention [36].Donor adverse events like citrate toxicity, hematoma and vasovagal reactions were observed in 40 donors (1.33%) and were comparable in both the machines.Despite administering prophylactic oral calcium (1000 mg) as suggested by previous authors citrate toxicity was found in 20 out of the 40 affected donors in the present study.It was observed that 20% of procedures performed with prophylactic calcium were associated with symptoms, most of which were mild [38].The various reasons for these symptoms may include (a) donors who undergo the procedure repeatedly or for prolonged periods are susceptible to an accumulation of excess citrate leading to inappropriate metabolism by the body.(b) hypocalcaemia like symptoms may be caused by hypomagnesaemia and calcium supplementation becomes unfruitful, (c) apheresis procedures in donors with low normal platelet count take more time to achieve the target yield and result in higher infusion of acd, (d) symptoms may be due to suboptimal dose of prophylactic oral calcium because it has been observed that administration of 2000 mg of calcium carbonate was associated with a statistically significant reduction in the severity of paresthesia [38, 43], (e) we also predict that calcium dose and its time of administration play role in counter acting the effect of citrate metabolism.Both machines used in the present study consistently provided optimized platelet products irrespective of their variations in inherent working programs.Mean procedure time was significantly higher in amicus (79.6 min) than trima (64.3 min) (p = 0.02).As procedure time directly concerns the apheresis donors therefore it is an important parameter to evaluate the safety and comfort of healthy donors.Both machines exhibited comparable collection efficiency and acd utilization.Though significant ce variation was not observed in the present study (67.3% vs.66.1%) but ce is said to be greatly affected by platelet yield and post-procedure platelet which in turn depend on the donor population.The mean volume of final product was higher in the amicus compared trima accel but the difference was not significant.(p = 0.11).Mean yield of platelets in the final product, which is the most important quality parameter, was found to be comparable in both the machines (p = 0.061).In the present study 97.6% of the platelet product could achieve the target platelet yield of = 3 x 1011 against the recommended =75% or =90% published by national and international authorities respectively.In the present study the mean residual leukocyte content was observed to be 1.3 x 106 and 1.6 x 106 per sdp unit by trima accel and amicus respectively and all products complied with the aabb criteria of 5 x 106 leukocytes per unit the authors concluded that plateletpheresis using new generation automated cell separators have significantly optimized quality of sdp in terms of platelet yield, leukodepletion and red cell contamination in comparison to their older versions.Moreover an increase in collection efficiency, lesser whole blood processing, reduced procedure time and low utilization of anticoagulants greatly enhanced donor safety thereby ensuring donor retention, bigger voluntary donor pool and repeat donations.Further to prevent citrate related toxicity and recommendation by previous workers; apheresis centres may administer prophylactic oral calcium to donors in a dose of 1000¿2000 mg at least 30 min prior to the procedure.In relation to the lower than expected yield, based on existing internal risk assessments which incorporate risk to patients or donors compared to occurrence rates, this failure does not have a high risk.A risk assessment was conducted for the adverse events outlined in this study.According to the aabb technical manual, adverse reactions can occur at the time of donation or after the donor has left the blood center.In a comprehensive donor hemovigilance program reported by the american red cross, adverse reactions were reported for wb collections (349 in 10,000), plateletpheresis (578 in 10,000), and double rbc unit collections (538 in 10,000), the vast majority of which were minor presyncopal reactions and small hematomas.According to the aabb technical manual: vasovagal reactions (also referred to as pre-faint or presyncope) include dizziness, sweating, nausea, vomiting, weakness, apprehension, pallor, hypotension, and bradycardia.The reaction might progress to syncope (loss of consciousness); convulsions and loss of bladder and bowel function might also occur.Syncope can also result from orthostatic blood pressure changes after donation.Vasovagal reactions are distinguished by a low pulse rate, whereas reactions related to volume depletion are associated with an increased pulse rate.This difference, however, has no practical value, as both mechanisms are treated similarly.In case of vasovagal reaction, phlebotomy should be stopped, and the donor should be placed in a recumbent position¿ blood systems, inc, reported a rate of syncope during and after phlebotomy as 27 per 10,000 wb donations, with an associated injury rate of 1.3 per 10,000 wb donations.Approximately 10% of loss of consciousness reactions occur after the donor leaves the donation site.According to the aabb technical manual: citrate reactions: during apheresis, blood that is anticoagulated with citrate in the apheresis systems is returned to the donor at an acceptable rate.In healthy individuals, citrate is rapidly metabolized, but some donors can experience mild citrate reactions (paresthesias or tingling sensations).Oral calcium supplementation is advised for symptomatic management of hypocalcemia.Hypocalcemia has been noted with rapid transfusions.This is usually transient and dependent on the amount and rate of citrate infused.Calcium replacement may be administered based on the recipient¿s ionized serum calcium level and the rate of citrate administration.Venous access devices may cause thrombosis.Infrequently, their placement may result in severe complications, such as pneumothorax, arrhythmia, or perforation of the heart or great vessels, occurring with up to 1% of procedures.Other complications such as arterial puncture, deep hematomas, and av formation are more frequent, occurring with 1% to 3% of procedures.With further reference to needle-related injuries (such as a bruise or hematoma); bruises are the most common adverse event after phlebotomy, occurring in 23% of donors based on post donation interviews.Hematomas, defined as the accumulation of blood under the skin, are less common than bruises, occurring in 1.7% of donors.Bruises and minor hematomas (less than 2 by 2inches) generally do not prevent donors from donating again.Root cause: the authors reported collection efficiency issues as 2.6% sdp collected by trima accel could not met the target yield of = 3 x 1011.Historically, lower than expected yields can occur due to access pressure issues such as the inlet flow rate being too high and/or inadequate patient access.Other possible causes include but are not limited to the patient's blood physiology interfering with separation of the cellular components, or from not processing enough blood to optimize the collection of target cells.Platelet clumping can also interfere with the proper separation of cells in the connector and/or lrs chamber.Disposable defects, sampling errors, lab errors and channel loading errors can all contribute to the yield collection being lower than expected.A root cause assessment for the adverse patient reactions was performed for this complaint.The reported adverse events are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, donor's sensitivity to the procedure and/or hemodynamic stress of the procedure.A root cause assessment was performed for the hematomas.Hematomas can result from several potential root causes.These include, but are not limited to : - improper insertion technique: if the needle or catheter is inserted too quickly, at the wrong angle, or too forcefully, it can damage the blood vessels, leading to bleeding under the skin and forming a hematoma.Improper insertion techniques can also result in repetitive punctures which can also cause a hematoma.- vascular trauma: the device could inadvertently puncture a blood vessel, causing blood to leak out into surrounding tissue and form a hematoma.Inappropriate needle or catheter size: using a needle or catheter that is too large for the intended vein or tissue can cause significant trauma to the vessel walls, leading to bleeding.- patient/donor disease state/blood physiology; certain patient conditions like clotting disorders, anticoagulant therapy (e.G., warfarin or heparin), or fragile veins can increase the likelihood of hematoma formation.A root cause assessment was performed for the drop in ionized calcium.A decreased ionized calcium in circulation is a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, the citrate contents in the replacement fluid, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.These reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, the citrate contents in the replacement fluid, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.Citation: das, s.S., sen, s., zaman, r.U., & biswas, r.N.(2020).Plateletpheresis in the era of automation: optimizing donor safety and product quality using modern apheresis instruments.Indian journal of hematology and blood transfusion, 37(1), 134¿139.Https://doi.Org/10.1007/s12288-020-01337-1.
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Event or Problem Description
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Per journal article "plateletpheresis in the era of automation: optimizing donor safety and product quality using modern apheresis instruments".By das, s.S., sen, s., zaman, r.U., biswas, r.N.Abstract: the increases in major surgeries, transplantations and speciality clinics have significantly increased the utilization of platelet concentrates including single donor platelets (sdp).The advantages of sdp or apheresis platelet have been discussed elaborately by previous authors as compared to random donor platelets.Here we share our experiences of plateletpheresis procedures using the modern apheresis machines with regards to product quality and donor safety.This study included 3016 procedures of plateletpheresis (1397 on amicus and 1619 on trima accel cell separators) on eligible donors using recommended apheresis kits.A target yield of 3 9 1011 was set as the end point of each procedure.Donor details, procedure details and donor adverse reactions if any were documented.Statistical analysis was done using the spss statistical package (version 13, usa).Of the total 6276 donors screened 2049 (32.6%) were deferred due to various reasons.Out of remaining 4227 eligible donors; 3016 (71.4%) underwent plateletphereis procedures based on the requirement of sdp by the patients.Mean pre-procedure platelet count and hematocrit in donors were 188.3 9 106 / ml and 41.7% respectively.Mean procedure time in amicus (76.6 min) was significantly more than the trima accel (64.3 min) (p = 0.02).Platelet yield by trima accel and amicus was 2.96 9 1011 and 3.08 9 1011 respectively (p = 0.061).A total of 40 donors (1.33%) suffered adverse effect during or after apheresis procedures.While the modern plateletpheresis devices are both donor and user friendly at the same time they provide quality product consistently in lesser time.The collection set is not available for return because it was discarded by the customer.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events.This retrospective study included 3016 procedures of plateletpheresis from january 2013 to june 2019.All procedures were performed on eligible donors taking informed consent as per laws enacted in the drugs and cosmetic acts (dca), india.A request for any further specific patient information is not feasible.
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