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The journal article, 'leukapheresis in 15 patients weighing 20 kg or less: a single centre experience', discusses a study in which 15 children with acute lymphoblastic leukemia and acute myeloid leukemia (aml) and hyperleukocytosis were treated with the cobe spectra apheresis system in the general pediatric ward by the staff from the department of blood transfusion.26 leukapheresis procedures were performed.12 patients (80%) were performed with peripheral veins, others (20%) with femoral veins.Three patients with a platelet count less than 20 × 109/l after leukapheresis required platelet transfusions.There was a 60-day mortality rate of 13.3% (2 patients) by the end of the study.The two patients expired with severe pulmonary infections.This report is being filed due to patient injury/medical intervention, there is no allegation that the device caused or contributed to the mentioned deaths.Patient information is summarized in the article as, " fifteen patients weighing =20 kg with different types of leukaemia were enrolled.Five of the patients had t cell acute lymphoblastic leukaemia, 5 had b cell acute lymphoblastic leukaemia, 4 had acute myelogenous leukaemia (monocytic type m5) and 1 had an undiagnosed leukaemia.There were 10 male (66.7%) and 5 female patients (33.3%).The ages, heights and body weights of the patients ranged from 1 year and 10 months to 7 years, 80 to 113 cm, and 10 to 20 kg, respectively; the medians were 4 years, 103 cm and 15 kg, respectively." "paediatric patients included in the analysis: 1.All and an initial wbc count >400 × 109/l; 2.A wbc count >200 × 109/l with leukostasis with clinical signs such as dizziness, headache and altered sensorium; and 3.Aml and an initial wbc count >100 × 109/l in a patient who has undergone lk in our hospital.Only patients weighing 20 kg or less who underwent lk were included." this report is being filed for patient 6.This patient has t-all and the length of stay was 31days.Current status of the patient is deceased, however, this report is being filed due to patient injury/medical intervention, there is no allegation that the device caused or contributed to the death.The leukarpheresis sets are not available for return because they were discarded by the customer.
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This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in d.2 and d.4.Investigation: since this is a retrospective study that reviewed 15 children with acute lymphoblastic leukemia and acute myeloid leukemia and hyperleukocytosis who were treated with the cobe spectra apheresis system, the disposable sets were not available for return.In this study, 15 children with acute lymphoblastic leukemia (all) and acute myeloid leukemia (aml) and hyperleukocytosis were treated with the cobe spectra apheresis system in the general paediatric ward by the staff from the department of blood transfusion.26 lk procedures were performed.12 patients (80%) were performed with peripheral veins, others (20%) with femoral veins.Median age, body weight of the patients was 4 years (range from 1 year 10 month to 7 years) and 15 kg (range from10 to 20 kg).The median white blood cell (wbc) count of pre-first-lk was 289 × 10^9/l (range from 108 × 10^9/l to 579 × 10^9/l).The median decrease in wbc count after each lk was 34% (range from 14% to 54%), and overall decrease in wbc after completion of lk procedures was 45% (range from 15% to 70%).All of the patients had no further signs of leukostasis and achieved marked reductions in wbc counts.Only minor clinical adverse events were attributable to lk.With adequate monitoring and experienced team, lk is a safe and may be a beneficial leukoreduction method in small patients weighing 20 kg or less with all and aml.The cobe spectra apheresis system (terumobct, (b)(6),co, usa) under manual control of the standard mnc program(version 6.1) was used.The lk procedures were conducted by an apheresis operator from the department of blood transfusion in the paediatric ward.The wbc disposable tubing set was primed with normal saline andacd-a.Before connecting the tubing to the patient, 0.5-1 rbc units were added for a second prime to maintain haemodynamic stability in the paediatric patients with a total blood volume (tbv) less than 1893 ml; the haematocrit (hct) was not adjusted.The blood to anticoagulant ratio was changed to 1:50 to speed up the rbc priming rate, and the setting ratio was restored when the priming was finished.The collection parameters were as follows: the inlet flow was 10¿25 ml/min, the blood to acd-a ratio was 13-15:1, the col-lection rate was 3¿7 ml/min, and the inlet volume was 1-1.9 tbv.To avoid excess saline in the paediatric patients and to prevent circulatory overload, only normal red blood cells were rinsed back in the rbc return stage.The saline irrigation stage at the end of the lk procedure was omitted to keep the children in tbv balance.To prevent hypocalcaemia, 10 ml of 10% calcium gluconate was taken orally or intravenously.Fifteen patients weighing =20 kg with different types of leukaemia were enrolled.Five of the patients had t cell acute lymphoblastic leukaemia, 5 had b cell acute lymphoblastic leukaemia,4 had acute myelogenous leukaemia (monocytic type m5) and 1 had an undiagnosed leukaemia.There were 10 male (66.7%) and 5 female patients (33.3%).The ages, heights and bodyweights of the patients ranged from 1 year and 10 months to 7 years, 80 to 113 cm, and 10 to 20 kg, respectively; the medians were 4 years, 103 cm and 15 kg, respectively.The patient¿s clinical and biological characteristics are detailed in table 1.During the study period, 26 lk procedures were performed in15 patients.A total of 2-5 cycles were performed in 6 patients, whereas the other patients underwent only one cycle.The lk procedures were performed with the peripheral veins for 12 patients (80%) and with the femoral veins for 3 patients (20%) (table 1).In each procedure, the mean tbv, processed blood volume, and collection volume were 1401 ± 342 ml, 1888 ± 612 ml, and 285 ± 97 ml, respectively.Additionally, the mean acd-a volume was 136 ± 45 ml, the mean duration time was 96 ± 17 minutes, and the mean compensation volume was 276 ± 12 ml.The calcium-binding effect of acd-a can prevent coagulation in the blood circulation and reduce the serum ca2+levels [9].The laboratory findings for the aptt, pt, inr and [k+] had no significant change, which was in contrast to [ca2+] after lk (shown in table 2).Nevertheless, no clinical finding attributed to hypocalcaemia was observed.Both the systolic and diastolic pressure of all patients fluctuated in the range from ±5% of the baseline throughout the lk procedure.Additionally, 3 patients with a plt less than 20 × 109/l after lk received platelet transfusions.We observed a significant drop in the platelet counts post-lk, but this drop did not lead to coagulation disorders.All patients were given 10 ml of 10% calcium gluconate orally or intra-venously, and no hypocalcaemia was observed based on the clinical manifestation.However, the laboratory finding indicated that the serum ca2+level dropped and reached the diagnostic level for hypocalcaemia.Therefore, a prophylactic intravenous ca infusion should be given to low-weight patients with lk.Ten patients survived (fig.2).All of these patients continued with chemotherapy except patient no.9, who accepted a haploidentical bone marrow transplantation from his father.Three patients (patient nos.1, 2, and 5) had no further follow-up, and 2 patients (patient nos.6 and 13) expired with severe pulmonary infections.The mean length of the hospital stay was 43 ± 22 days (range from 11 to 93 days).The mean follow-up time of the patients was 10.7 ± 5.9 months (range from 1 to 20 months), with a 30-daymortality rate of (b)(4) and a 60-day mortality rate of (b)(4) by the end of the study.Since this is a retrospective study that reviewed 15 children with acute lymphoblastic leukemia and acute myeloid leukemia and hyperleukocytosis who were treated with the cobe spectra apheresis system, the lot numbers were not provided; therefore, a disposable lot history search could not be conducted.Since this is a retrospective study that reviewed 15 children with acute lymphoblastic leukemia and acute myeloid leukemia and hyperleukocytosis who were treated with the cobe spectra apheresis system, 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.According to therapeutic apheresis: a physician's handbook, with current centrifugal technology, reductions in platelet count are usually modest, and levels quickly return to baseline.In a severely thrombocytopenic patient, however, such a loss may mask the beginning of platelet recovery.Similarly, the small amount of red cells lost in the apheresis circuit may be more apparent in an anemic patient who has meager production capacity and who is receiving multiple procedures.Although generally well tolerated, the large-volume leukocytapheresis for stem cell collections in patients often results in a decline in hematocrit and platelet count, particularly because some red cells and platelets are incidentally removed with the stem cells.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Article citation: f zeng, h huang, d fu, q huang, l fan, s wei.Leukapheresis in 15patients weighing 20kg or less: a single centre experience.Transfusion and apheresis science.56(2017): 889-893.Root cause: a root cause assessment for platelet losses was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: - patient's underlying disease state - clumping in the extracorporeal system - running a lengthy procedure - collect flow rate was set too high the reported other adverse events (hypotension) 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 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.
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The journal article, 'leukapheresis in 15 patients weighing 20 kg or less: a single centre experience', discusses a study in which 15 children with acute lymphoblastic leukemia and acute myeloid leukemia (aml) and hyperleukocytosis were treated with the cobe spectra apheresis system in the general pediatric ward by the staff from the department of blood transfusion.26 leukapheresis procedures were performed.12 patients (80%) were performed with peripheral veins, others (20%) with femoral veins.Three patients with a platelet count less than 20 × 109/l after leukapheresis required platelet transfusions.There was a 60-day mortality rate of 13.3% (2 patients) by the end of the study.The two patients expired with severe pulmonary infections.This report is being filed due to patient injury/medical intervention, there is no allegation that the device caused or contributed to the mentioned deaths.Patient information is summarized in the article as, " fifteen patients weighing =20 kg with different types of leukaemia were enrolled.Five of the patients had t cell acute lymphoblastic leukaemia, 5 had b cell acute lymphoblastic leukaemia, 4 had acute myelogenous leukaemia (monocytic type m5) and 1 had an undiagnosed leukaemia.There were 10 male (66.7%) and 5 female patients (33.3%).The ages, heights and body weights of the patients ranged from 1 year and 10 months to 7 years, 80 to 113 cm, and 10 to 20 kg, respectively; the medians were 4 years, 103 cm and 15 kg, respectively." "paediatric patients included in the analysis: 1.All and an initial wbc count >400 × 109/l; 2.A wbc count >200 × 109/l with leukostasis with clinical signs such as dizziness, headache and altered sensorium; and 3.Aml and an initial wbc count >100 × 109/l in a patient who has undergone lk in our hospital.Only patients weighing 20 kg or less who underwent lk were included." this report is being filed for patient 6.This patient has t-all and the length of stay was 31days.Current status of the patient is deceased, however, this report is being filed due to patient injury/medical intervention, there is no allegation that the device caused or contributed to the death.The leukarpheresis sets are not available for return because they were discarded by the customer.
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