| Catalog Number |
12320 |
| 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 |
Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144); Convulsion/Seizure (4406); Paresthesia (4421); Unspecified Gastrointestinal Problem (4491)
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| Date of Event |
01/30/2025
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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Investigation: in this paper, we will discuss the evolution from a physician-led to a nurse-led apheresis service and its impact on patient outcomes in a pediatric restructured hospital.The in-house apheresis service started in 1999.Prior to this, pediatric patients who required collection of peripheral hematopoietic progenitor cells (hpc) would have the procedure performed in another restructured hospital with pediatric apheresis support.Having this service set up within the pediatric hospital predominately allowed apheresis procedures to be performed promptly for pediatric patients across the different subspecialties.The service also utilized onsite intensive care support.The original service was set up with two physicians and a transplant coordinator who was trained in carrying out apheresis procedures.The two physicians included the program director (pd) of the hsct program, who was responsible for overseeing and managing cell collection and processing.The second physician was a transplant physician who specialized in providing care for patients undergoing hematopoietic stem cell transplant.The service primarily provided only stem cell collection; however, since 2020, the team has started supporting both peripheral hpc and therapeutic apheresis, with 10¿15 therapeutic apheresis procedures performed yearly.Prior to that, therapeutic apheresis was carried out by the intensivist using a membrane-based machine.As the service needs increased, ans were recruited to be part of the team.The service was initially set up as a physician-led program for which cases were referred directly to pd and were scheduled based on the availability of the trained ans.The decision to start the collection was initiated by pd after confirming the availability of ans.Ans solely focused on the technical aspect of cell collection and did not influence the decision of cell collection target and processing.The pd would be responsible for such a decision.In the absence of the pd, the primary physicians would have to assume the responsibility of cell collection target and processing.However, they were often the medical oncologist or hematologist in charge of the patient and might not be familiar with apheresis.Due to limited manpower, the service faced significant challenges in providing extended support.Although the number of physicians increased over the years, not all of them were trained to perform the apheresis procedures.The team took this opportunity to increase the pool of trained nurses by recruiting and training another two ans.This temporarily helped to stabilize the service but was deemed insufficient to support, as the demand for advanced cellular therapies continued to grow rapidly.Despite the covid-19 pandemic, there was ongoing recruitment for academic in-house single cd19 and dual cd19/cd22 chimeric antigen receptor (car) t-cell trials.A new treatment modality, including extracorporeal photopheresis (ecp) for chronic graft-versus- host disease (gvhd), was started in 2020.Besides apheresis for these interventions, the service also embarked on the use of apheresis for the development of novel therapies such as covid-directed t-cell and adoptive cellular therapy for post-transplant cases with cytomegalovirus (cmv) and adenovirus reactivation.There was a need to increase service capacity with existing limited resources.Thus, a new service model was considered to empower trained ans to take on a more active role in leading the apheresis service utilizing protocolized practice.To streamline processes and improve service efficacy, the existing apheresis workflows were revised.In 2022, the new nurse-led service model was formed and explored initiatives to increase the pool of trained ans.As little is known and published about apheresis nursing education, training continued to be provided by clinical specialist from vendor company.For the initial training, the clinical specialist from the company would provide a 3-day onsite theory and hands-on practice.The newly trained ans would then undergo a period of clinical tagging with experienced ans until they were assessed to be competent.A 6-monthly competency assessment was mandatory for all trained ans.Re-training would be required if ans failed to maintain regular apheresis competency.With the number of ans being doubled since 2017 and along with the new service model, there were a few changes made, such as the ans were then rostered on a bi-weekly basis to cover the service.This scheduled roster allowed the an covering to accept the referral for apheresis directly from primary physicians.Then, the an would inform the pd of the referral while arranging for manpower support that allowed timely response to the patient's clinical need.In this nurse-led service, the ans oversaw and coordinated the apheresis schedule of patient and circulated the information to both the medical and nursing team.Cases referred to the apheresis service would be scheduled and assigned to the earliest available procedural dates.For cell collections, ans worked closely with both the pd and primary physician using standardized mobilization protocol with subcutaneous granulocyte colony-stimulating factor for both autologous and allogenic donors.Ans were empowered to directly consult the pd and/or primary physician for the need for alternative mobilization methods if the cd34+ cell count was suboptimal to start collection.In the absence of pd, ans were empowered to lead the cell collection discussion with the primary physician.This helped to bridge the gaps in communication and ensured standard protocol adherence.As the number of trained ans doubled over the 1-year period, they were more confident in leading the service, and with enhanced manpower coverage, the service had been able to meet clinical demand while maintaining all key performance indicators of the collection facility.To ensure patient's safety and all key indicators met, pd continued to be responsible for the evaluation and oversight of each case of cell collection by apheresis and each case of therapeutic apheresis.The data from our program is submitted to center for international blood & marrow transplant research for international benchmarking.The data presented in this paper were obtained as part of the ongoing review of the efficacy of cell collection and the new nurse-led service model.Therefore, approval from the institutional review board was not required as per institutional guidelines for data collection and publication.The service utilized the spectra optia apheresis system, as it was associated with higher cell collection efficiency, superior quality of peripheral hpc products, and therapeutic apheresis was performed using a centrifugal system.From 2017 to 2023, 100 patients with a median age of 8.5 years old were referred, and a total of 195 apheresis procedures were performed.Sixty-six percent (n = 128) of the apheresis procedures were cell collections, and 34% (n = 67) were therapeutic apheresis.Cell collections were predominantly from neuroblastoma patients, whereas the majority of therapeutic apheresis was performed on patients with severe aplastic anemia.The median days of cell collection were 1, across both mobilized hpc collection and non-mobilized hpc collection, with a maximum of 4 days and 2 days of collection, respectively.Patient characteristics, procedure characteristic, and reported adverse events were plotted and reflected in table 1a¿c, respectively.Seventeen adverse events were reported during the apheresis procedures from 2017 to 2023.Among these, 15 events were minor, and 2 were major (1 seizure, 1 anaphylactic shock).The 2 major side effects were associated with therapeutic apheresis; procedures, and no adverse event was reported.Since 2022, ans received direct referrals for the therapeutic apheresis.The decision about the total duration and the frequency of therapeutic apheresis procedures is shared between ans and the primary physician of patients.Since the evolvement of the nurse-led model, the service was able to handle the increased demand for both cell collection and therapeutic apheresis with comparable efficacy and excellent safety record.This new model has been well recognized within the hospital and ans are trusted to lead subsequent service expansion.Both occurred before the establishment of the nurse-led model.Mild side effects such as tingling sensation felt (around lips, fingers, and/or toes) and gastrointestinal issues accounted for 70% and 18% of total adverse events, respectively.These mild side effects were then quickly resolved upon decreasing the inlet flow rate during the cell collection.There were no reported major adverse events for all cell collections.The total number of mobilized hpc collections and cell collection outcomes from 2017 to 2023 were documented and tabulated separately in table 2a¿previous service model (2017¿ 2021) and table 2b¿nurse-led service model (2022¿2023).The data collected for autologous and allogenic cell collections were then further segregated into the number of days of cell collection and cell yield.Over the 5-year span from 2017 to 2021, 92 mobilized hpc collection procedures were conducted.Of these, 34% achieved the targeted cell yield on the first day, whilst another 34% necessitated a second day of harvesting.Target cell yield was only achieved beyond 2 days of harvesting in 20%, and a further 10% did not achieve the optimal required yield.In the first year following the launch of the nurse-led service, 17 mobilized hpc collection procedures were carried out.This figure was comparable to the average number of procedures conducted annually over the preceding 5-year period.More than half of the targeted cell yield were achieved on the first day, with up to 94% of them achieved by the second day.While 1 of the collection did not achieve the targeted cell yield, no collection was is needed beyond 2 days.Between 2017 and 2021, there were four unmobilized mnc collection for car-t cells manufacturing.Since the initiation of nurse-led service, the number of unmobilized mnc collections tripled, as shown in table 2c.Lymphocyte subsets were used as a pre-collection determinant instead of cd34+ cell count.There were no reported adverse events for both periods.In addition to cell collections, the ans also performed therapeutic apheresis from 2020.The total number of therapeutic plasma exchange procedures performed were 54, with a median of five procedures per patient.Between 2020 and 2021, two patients were reported to have developed major side effects.One patient suffered a seizure, and the other patient developed signs and symptoms of severe anaphylactic shock.In each case, the exchange was held off immediately, and necessary medical treatments were rendered accordingly.As there were large amounts of plasma used during tpe, investigations for queried transfusion reactions were performed, and results concluded that both patients had developed severe allergic reactions to the plasma proteins.These two cases further highlighted the need for tpe to be performed in the intensive care unit with trained ans due to the potential adverse events.Extracorporeal photopheresis (ecp) is a treatment option when gvhd becomes refractory or dependent on first-line steroids.Ecp was first performed in 2020 for patients with grade 4 lung gvhd.This was the case of high-risk acute myeloid leukemia who underwent urgent haplo-identical stem cell transplant with 70% blast in bone marrow.Patients remained clinically stable throughout the 13 ecp procedures, and no adverse event was reported.Since 2022, ans received direct referrals for the therapeutic apheresis.The decision about the total duration and the frequency of therapeutic apheresis procedures is shared between ans and the primary physician of patients.Since the evolvement of the nurse-led model, the service was able to handle the increased demand for both cell collection and therapeutic apheresis with comparable efficacy and excellent safety record.This new model has been well recognized within the hospital and ans are trusted to lead subsequent service expansion.Since this was a journal publication of an ongoing review of the efficacy of cell collection and the new nurse-led service model from 2017¿2023, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted according to the aabb circular of information for the use of human blood components (revised 2017), allergic reactions frequently occur (ie, 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually respond 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.Investigation is in process and a follow-up report will be provided.Anh, p.T.N., zhong, x., lim, s.L.Y., periakaruppan, p.W., & k, v.(2025).Nurse-led apheresis service in a pediatric restructured hospital: the past, the present, and the future.Journal of clinical apheresis, 40(1).Https://doi.Org/10.1002/jca.70009.
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Event or Problem Description
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Per journal article ¿nurse-led apheresis service in a pediatric restructured hospital: the past, the present, and the future¿, by anh, p.T.N., zhong, x., lim, s.L.Y., periakaruppan, p.W., & k, v., apheresis nurses are well equipped with not only the critical thinking skills but also the important aspects of operating the apheresis machine.As the demand for advanced cellular therapies grew, there was a need to recruit and train more nurses to be competent in apheresis nursing.A new service model was evolved from a physician-led to a nurse-led apheresis service, which empowered the apheresis nurses to lead the service.Since the commencement of the nurse-led service, a total of 32 peripheral hematopoietic progenitor cells collections were documented, and the outcomes of the cell yield were tabulated to study the collection efficiency.Ninety-four percent of the targeted cell yield was achieved with no collections needing beyond 2 days of harvesting.No apheresis-related major adverse event was reported following the implementation of the new service model too.The service utilized the spectra optia apheresis system, as it was associated with higher cell collection efficiency, superior quality of peripheral hpc products, and therapeutic apheresis was performed using a centrifugal system.From 2017 to 2023, 100 patients with a median age of 8.5 years old were referred, and a total of 195 apheresis procedures were performed.Sixty-six percent (n=128) of the apheresis procedures were cell collections, and 34% (n=67) were therapeutic apheresis.Seventeen adverse events were reported during the apheresis procedures from 2017 to 2023.Among these, 15 events were minor, and 2 were major (1 seizure, 1 anaphylactic shock).Between 2020 and 2021, two patients were reported to have developed major side effects.One patient suffered a seizure, and the other patient developed signs and symptoms of severe anaphylactic shock.In each case, the exchange was held off immediately, and necessary medical treatments were rendered accordingly.As there were large amounts of plasma used during therapeutic plasma exchange (tpe), investigations for queried transfusion reactions were performed, and results concluded that both patients had developed severe allergic reactions to the plasma proteins.Mild side effects were quickly resolved upon decreasing the inlet flow rate during the cell collection.There were no reported major adverse events for all cell collections.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.The set is not available for return because it was discarded by the customer.
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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: in this paper, we will discuss the evolution from a physician-led to a nurse-led apheresis service and its impact on patient outcomes in a pediatric restructured hospital.The in-house apheresis service started in 1999.Prior to this, pediatric patients who required collection of peripheral hematopoietic progenitor cells (hpc) would have the procedure performed in another restructured hospital with pediatric apheresis support.Having this service set up within the pediatric hospital predominately allowed apheresis procedures to be performed promptly for pediatric patients across the different subspecialties.The service also utilized onsite intensive care support.The original service was set up with two physicians and a transplant coordinator who was trained in carrying out apheresis procedures.The two physicians included the program director (pd) of the hsct program, who was responsible for overseeing and managing cell collection and processing.The second physician was a transplant physician who specialized in providing care for patients undergoing hematopoietic stem cell transplant.The service primarily provided only stem cell collection; however, since 2020, the team has started supporting both peripheral hpc and therapeutic apheresis, with 10¿15 therapeutic apheresis procedures performed yearly.Prior to that, therapeutic apheresis was carried out by the intensivist using a membrane-based machine.As the service needs increased, ans were recruited to be part of the team.The service was initially set up as a physician-led program for which cases were referred directly to pd and were scheduled based on the availability of the trained ans.The decision to start the collection was initiated by pd after confirming the availability of ans.Ans solely focused on the technical aspect of cell collection and did not influence the decision of cell collection target and processing.The pd would be responsible for such a decision.In the absence of the pd, the primary physicians would have to assume the responsibility of cell collection target and processing.However, they were often the medical oncologist or hematologist in charge of the patient and might not be familiar with apheresis.Due to limited manpower, the service faced significant challenges in providing extended support.Although the number of physicians increased over the years, not all of them were trained to perform the apheresis procedures.The team took this opportunity to increase the pool of trained nurses by recruiting and training another two ans.This temporarily helped to stabilize the service but was deemed insufficient to support, as the demand for advanced cellular therapies continued to grow rapidly.Despite the covid-19 pandemic, there was ongoing recruitment for academic in-house single cd19 and dual cd19/cd22 chimeric antigen receptor (car) t-cell trials.A new treatment modality, including extracorporeal photopheresis (ecp) for chronic graft-versus- host disease (gvhd), was started in 2020.Besides apheresis for these interventions, the service also embarked on the use of apheresis for the development of novel therapies such as covid-directed t-cell and adoptive cellular therapy for post-transplant cases with cytomegalovirus (cmv) and adenovirus reactivation.There was a need to increase service capacity with existing limited resources.Thus, a new service model was considered to empower trained ans to take on a more active role in leading the apheresis service utilizing protocolized practice.To streamline processes and improve service efficacy, the existing apheresis workflows were revised.In 2022, the new nurse-led service model was formed and explored initiatives to increase the pool of trained ans.As little is known and published about apheresis nursing education, training continued to be provided by clinical specialist from vendor company.For the initial training, the clinical specialist from the company would provide a 3-day onsite theory and hands-on practice.The newly trained ans would then undergo a period of clinical tagging with experienced ans until they were assessed to be competent.A 6-monthly competency assessment was mandatory for all trained ans.Re-training would be required if ans failed to maintain regular apheresis competency.With the number of ans being doubled since 2017 and along with the new service model, there were a few changes made, such as the ans were then rostered on a bi-weekly basis to cover the service.This scheduled roster allowed the an covering to accept the referral for apheresis directly from primary physicians.Then, the an would inform the pd of the referral while arranging for manpower support that allowed timely response to the patient's clinical need.In this nurse-led service, the ans oversaw and coordinated the apheresis schedule of patient and circulated the information to both the medical and nursing team.Cases referred to the apheresis service would be scheduled and assigned to the earliest available procedural dates.For cell collections, ans worked closely with both the pd and primary physician using standardized mobilization protocol with subcutaneous granulocyte colony-stimulating factor for both autologous and allogenic donors.Ans were empowered to directly consult the pd and/or primary physician for the need for alternative mobilization methods if the cd34+ cell count was suboptimal to start collection.In the absence of pd, ans were empowered to lead the cell collection discussion with the primary physician.This helped to bridge the gaps in communication and ensured standard protocol adherence.As the number of trained ans doubled over the 1-year period, they were more confident in leading the service, and with enhanced manpower coverage, the service had been able to meet clinical demand while maintaining all key performance indicators of the collection facility.To ensure patient's safety and all key indicators met, pd continued to be responsible for the evaluation and oversight of each case of cell collection by apheresis and each case of therapeutic apheresis.The data from our program is submitted to center for international blood & marrow transplant research for international benchmarking.The data presented in this paper were obtained as part of the ongoing review of the efficacy of cell collection and the new nurse-led service model.Therefore, approval from the institutional review board was not required as per institutional guidelines for data collection and publication.The service utilized the spectra optia apheresis system, as it was associated with higher cell collection efficiency, superior quality of peripheral hpc products, and therapeutic apheresis was performed using a centrifugal system.From 2017 to 2023, 100 patients with a median age of 8.5 years old were referred, and a total of 195 apheresis procedures were performed.Sixty-six percent (n = 128) of the apheresis procedures were cell collections, and 34% (n = 67) were therapeutic apheresis.Cell collections were predominantly from neuroblastoma patients, whereas the majority of therapeutic apheresis was performed on patients with severe aplastic anemia.The median days of cell collection were 1, across both mobilized hpc collection and non-mobilized hpc collection, with a maximum of 4 days and 2 days of collection, respectively.Patient characteristics, procedure characteristic, and reported adverse events were plotted and reflected in table 1a¿c, respectively.Seventeen adverse events were reported during the apheresis procedures from 2017 to 2023.Among these, 15 events were minor, and 2 were major (1 seizure, 1 anaphylactic shock).The 2 major side effects were associated with therapeutic apheresis; procedures, and no adverse event was reported.Since 2022, ans received direct referrals for the therapeutic apheresis.The decision about the total duration and the frequency of therapeutic apheresis procedures is shared between ans and the primary physician of patients.Since the evolvement of the nurse-led model, the service was able to handle the increased demand for both cell collection and therapeutic apheresis with comparable efficacy and excellent safety record.This new model has been well recognized within the hospital and ans are trusted to lead subsequent service expansion.Both occurred before the establishment of the nurse-led model.Mild side effects such as tingling sensation felt (around lips, fingers, and/or toes) and gastrointestinal issues accounted for 70% and 18% of total adverse events, respectively.These mild side effects were then quickly resolved upon decreasing the inlet flow rate during the cell collection.There were no reported major adverse events for all cell collections.The total number of mobilized hpc collections and cell collection outcomes from 2017 to 2023 were documented and tabulated separately in table 2a¿previous service model (2017¿ 2021) and table 2b¿nurse-led service model (2022¿2023).The data collected for autologous and allogenic cell collections were then further segregated into the number of days of cell collection and cell yield.Over the 5-year span from 2017 to 2021, 92 mobilized hpc collection procedures were conducted.Of these, 34% achieved the targeted cell yield on the first day, whilst another 34% necessitated a second day of harvesting.Target cell yield was only achieved beyond 2 days of harvesting in 20%, and a further 10% did not achieve the optimal required yield.In the first year following the launch of the nurse-led service, 17 mobilized hpc collection procedures were carried out.This figure was comparable to the average number of procedures conducted annually over the preceding 5-year period.More than half of the targeted cell yield were achieved on the first day, with up to 94% of them achieved by the second day.While 1 of the collection did not achieve the targeted cell yield, no collection was is needed beyond 2 days.Between 2017 and 2021, there were four unmobilized mnc collection for car-t cells manufacturing.Since the initiation of nurse-led service, the number of unmobilized mnc collections tripled, as shown in table 2c.Lymphocyte subsets were used as a pre-collection determinant instead of cd34+ cell count.There were no reported adverse events for both periods.In addition to cell collections, the ans also performed therapeutic apheresis from 2020.The total number of therapeutic plasma exchange procedures performed were 54, with a median of five procedures per patient.Between 2020 and 2021, two patients were reported to have developed major side effects.One patient suffered a seizure, and the other patient developed signs and symptoms of severe anaphylactic shock.In each case, the exchange was held off immediately, and necessary medical treatments were rendered accordingly.As there were large amounts of plasma used during tpe, investigations for queried transfusion reactions were performed, and results concluded that both patients had developed severe allergic reactions to the plasma proteins.These two cases further highlighted the need for tpe to be performed in the intensive care unit with trained ans due to the potential adverse events.Extracorporeal photopheresis (ecp) is a treatment option when gvhd becomes refractory or dependent on first-line steroids.Ecp was first performed in 2020 for patients with grade 4 lung gvhd.This was the case of high-risk acute myeloid leukemia who underwent urgent haplo-identical stem cell transplant with 70% blast in bone marrow.Patients remained clinically stable throughout the 13 ecp procedures, and no adverse event was reported.Since 2022, ans received direct referrals for the therapeutic apheresis.The decision about the total duration and the frequency of therapeutic apheresis procedures is shared between ans and the primary physician of patients.Since the evolvement of the nurse-led model, the service was able to handle the increased demand for both cell collection and therapeutic apheresis with comparable efficacy and excellent safety record.This new model has been well recognized within the hospital and ans are trusted to lead subsequent service expansion.A request for lot numbers is not feasible because there are many months between collection of data, to peer review, to final publication.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 of an ongoing review of the efficacy of cell collection and the new nurse-led service model from 2017¿2023, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.According to the aabb circular of information for the use of human blood components (revised 2017), allergic reactions frequently occur (ie, 1-3% of plasma-containing components) as mild or self-limiting urticaria or wheezing that usually respond 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.Root cause: a root cause assessment was performed for the reported hypocalcemia.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.A root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined.Vasovagal are common side effects of therapeutic apheresis procedures.They are typically caused by the patient's disease state, the rate of ac infusion, the length of the procedure, the patient's sensitivity to the procedure and/or the hemodynamic stress of the procedure.A root cause assessment was performed for the two reports of severe adverse reactions.The authors stated that ¿one patient suffered a seizure, and the other patient developed signs and symptoms of severe anaphylactic shock.In each case, the exchange was held off immediately, and necessary medical treatments were rendered accordingly.As there were large amounts of plasma used during tpe, investigations for queried transfusion reactions were performed, and results concluded that both patients had developed severe allergic reactions to the plasma proteins.¿ a root cause assessment was performed for the low yield.Based on the available information a definitive root cause could not be determined.Potential causes for the low mnc or low cd34 stem cell collection efficiency include but are not limited to: - patient's blood physiology interferes with separation of cellular components - not processing enough blood to optimize the collection of target cells - poor mobilization of target cells due to patient's physiology and mobilization regimen - incorrect setting of collection preference - poor access, which resulted in pump pauses and caused the system to repeatedly re-establish the interface - platelet clumping which can interfere with proper separation of cells in the connector and can also cause system to repeatedly re-establish the interface.- lighting is too bright and is not within the appropriate range - dirty aperture plate and/or reference block anh, p.T.N., zhong, x., lim, s.L.Y., periakaruppan, p.W., & k, v.(2025).Nurse-led apheresis service in a pediatric restructured hospital: the past, the present, and the future.Journal of clinical apheresis, 40(1).Https://doi.Org/10.1002/jca.70009.
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Event or Problem Description
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Per journal article ¿nurse-led apheresis service in a pediatric restructured hospital: the past, the present, and the future¿, by anh, p.T.N., zhong, x., lim, s.L.Y., periakaruppan, p.W., & k, v., apheresis nurses are well equipped with not only the critical thinking skills but also the important aspects of operating the apheresis machine.As the demand for advanced cellular therapies grew, there was a need to recruit and train more nurses to be competent in apheresis nursing.A new service model was evolved from a physician-led to a nurse-led apheresis service, which empowered the apheresis nurses to lead the service.Since the commencement of the nurse-led service, a total of 32 peripheral hematopoietic progenitor cells collections were documented, and the outcomes of the cell yield were tabulated to study the collection efficiency.Ninety-four percent of the targeted cell yield was achieved with no collections needing beyond 2 days of harvesting.No apheresis-related major adverse event was reported following the implementation of the new service model too.The service utilized the spectra optia apheresis system, as it was associated with higher cell collection efficiency, superior quality of peripheral hpc products, and therapeutic apheresis was performed using a centrifugal system.From 2017 to 2023, 100 patients with a median age of 8.5 years old were referred, and a total of 195 apheresis procedures were performed.Sixty-six percent (n=128) of the apheresis procedures were cell collections, and 34% (n=67) were therapeutic apheresis.Seventeen adverse events were reported during the apheresis procedures from 2017 to 2023.Among these, 15 events were minor, and 2 were major (1 seizure, 1 anaphylactic shock).Between 2020 and 2021, two patients were reported to have developed major side effects.One patient suffered a seizure, and the other patient developed signs and symptoms of severe anaphylactic shock.In each case, the exchange was held off immediately, and necessary medical treatments were rendered accordingly.As there were large amounts of plasma used during therapeutic plasma exchange (tpe), investigations for queried transfusion reactions were performed, and results concluded that both patients had developed severe allergic reactions to the plasma proteins.Mild side effects were quickly resolved upon decreasing the inlet flow rate during the cell collection.There were no reported major adverse events for all cell collections.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.The set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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