| Catalog Number |
10220 |
| 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 |
Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Tachycardia (2095); Chills (2191); Urticaria (2278)
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| Date of Event |
03/12/2024
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Type of Reportable Event
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Serious Injury
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Event or Problem Description
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Per journal article, "efficacy and safety of therapeutic plasma exchange in children with neuroimmunological disorders: a limited unicentral study", by nikkhah, a., nasehi, m.M., momtazmanesh, n., etemad, k., & hajatnia, s., patients received therapeutic plasma exchange (tpe) with a combination of fresh frozen plasma (ffp) (80-20%) and 5% albumin with 5-10 cycles every other day.Patients with pulmonary non-infectious disease (pnid) received 121 tpe cycles.The present research investigated tpe-related complications in subgroups.Out of all the tpe cycles, three cycles (2.48%) in the autoimmune encephalitis (aie) subgroup, two (1.65%) in guillain-barre syndrome (gbs), five (4.13%) in multiple sclerosis (ms), and one (0.82%) in acute disseminated encephalomyelitis (adem), and no cycles in neuromyelitis optic spectrum disorder (nmosd) and optic neuritis (on) subgroups showed adverse effects.Grade 1 (as per ctcae) chill was observed in three cycles (2.48%) of ms and aie patients, grade 1 tachycardia in 3 cycles (2.48%) of gbs, ms, and aie patients, grade 3 urticaria in two cycles (1.65%) of gbs and patients with ms.Moreover, grade 2 hypertension, grade 1 dyspnea, and grade 1 nausea were observed in one cycle (0.83%) of aie, ms, and adem patients, respectively.One dose of hydrocortisone was injected iv to treat urticaria, and enalapril was used to control hypertension; none induced hemorrhage or infection.In this study, patients received a combination of ffp and 5% albumin throughout cycles.A patient developed tachycardia, hypertension, and chill simultaneously with symptoms of autonomic dysfunction during their disease.Therefore, it is challenging to understand if the hypotension was due to disease pathology or tpe.The most problematic cycles with several adverse effects, including chill and urticaria, were for a 73 kg 14-year-old girl in the ms subgroup, presumably because of being overweight (bmi = 26.8 kg/m2 -94% at risk).Furthermore, it can be related to a higher plasma dose, more plasma usage, and more susceptibility to allergy.The findings indicated that patients with ms experienced the most incidence of complications.Per the journal article the patient's adverse events were temporary and curable.No severe complications were observed, and tpe was generally well tolerated.No mortalities were recorded during the process.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.The platelet collection set is not available for return because it was discarded by the customer.
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Additional Manufacturer Narrative
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Investigation: lot number, manufacture, and expiry date are not available at this time. investigation is in process, a follow-up report will be provided.Citation: nikkhah, a., nasehi, m.M., momtazmanesh, n., etemad, k., & hajatnia, s.(2024).Efficacy and safety of therapeutic plasma exchange in children with neuroimmunological disorders: a limited unicentral study.Pubmed, 18(2), 31¿41.Https://doi.Org/10.22037/ijcn.V18i1.40139.
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Additional Manufacturer Narrative
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This report is being filed to provide a correction in d.1, d.2a, d.2b, d.3 and additional information in h.6 and h.11.Investigation: lot number, manufacture, and expiry date are not available at this time.An investigation was conducted for a journal article that references terumo bct product.Journal article, titled efficacy and safety of therapeutic plasma exchange in children with neuroimmunological disorders: a limited unicentral study by nikkhah et al was reviewed with primary purpose of screening for allegations of terumo bct device causing or contributing to death/injury or device malfunctions.Investigational details: objectives therapeutic plasma exchange (tpe) is a plasmapheresis procedure whose safety data for pediatric neuro-immunological disorders (pnid) is confined.The present research documents tpes safety and feasibility data in these conditions.Materials & methods the current study involved six distinct groups of patients with pnid undergoing tpe: neuromyelitis optic spectrum disorder (nmosd), autoimmune encephalitis (aie), acute disseminated encephalomyelitis (adem), multiple sclerosis (ms), guillain-barre syndrome (gbs), and optic neuritis (on).This study documented complications related to each tpe process.In addition, tpes efficacy was studied in these patients.Results the present study recorded adverse effects in 18 patients with pnid that received 121 tpe cycles: five cycles (4.13%) in ms, three (2.48%) in aie subgroup, one (0.82%) in adem, and two (1.65%) in gbs.No severe complications were observed among the patients.Conclusion patients with pnid tolerated therapeutic plasma exchange, which was a safe process.Summary of terumo bct product in relation to the journal article: materials & methods tpe was generally applied after 3-5 days of treatment with intravenous immunoglobulin, high-dose corticosteroids, or both.In the tpe technique, the interventional radiology or surgery team inserted a double-lumen apheresis catheter under sedation.Depending on their clinical condition, patients were admitted to the pediatric intensive care unit or the pediatric neurology ward.The present study used a spectra optia apheresis machine-61000 (manufactured by terumo bct, inc., lakewood, colorado) for tpe procedures.Before performing tpe, this study obtained cbc, pt, ptt, inr, bun, cr, and electrolyte levels.Typically, the researchers exchanged plasma volume with a mixture of ffp and 5% albumin (80% to 20% ratio).All patients received prophylactically calcium gluconate (1-2 grams) during each procedure.In patients 20 kg, this research used 250 ml packed rbcs to prime the device, precluding hemodynamic instability.Tpe was performed for all patients every other day for 5-10 cycles, exchanging one plasma volume for each.Blood laboratory values were monitored prior to each tpe process.This study tailored the tpe frequency on a daily patient evaluation basis.Common terminology criteria for adverse events severity (ctcae) scored the adverse events (13).Improvement in therapy was evaluated daily based on neurological exams and caregivers' subjective views on outcomes after initiating therapy.Spss software (version 28) performed statistical analyses (spss inc, chicago, il).The software analyzed the descriptive statistics and standard deviations.Results the current study studied 18 patients who underwent 121 tpe procedure cycles (table 2).The initial diagnosis of diseases included nmosd in 4 (22.2%), aie in four (22.2%), ms in four (22.2%), adem in one (5.6%), gbs in 4 (22.2%), and on in one (5.6%) patients (figure 1).The median onset age of presentation was 11.1 years, ranging from four to 15 years.Figure 2 shows the patients age distribution in distinct age groups.The female/male ratio was 1/1.Two patients in the aie subgroup had antibodies for nmda receptors; one was positive for voltage-gated potassium channel (vgkc), one in the nmosd subgroup was positive for aquaporin 4, and two in the ms subgroup were ocb-positive.Prior to tpe, four patients (22.2%) received ivig, eight (44.4%) received steroids, and five (27.7%) received both, while one patient (5.6%) did not receive any of the treatments before or after tpe.Patients received tpe with a combination of fresh frozen plasma (80-20%) and 5% albumin with 5-10 cycles every other day.Patients with pnid received 121 tpe cycles.The present research investigated tpe-related complications in subgroups (table 3).Out of all the tpe cycles, three cycles (2.48%) in the aie subgroup, two (1.65%) in gbs, five (4.13%) in ms, and one (0.82%) in adem, and no cycles in nmosd and on subgroups showed adverse effects.Grade 1 (as per ctcae) chill was observed in three cycles (2.48%) of ms and aie patients, grade 1 tachycardia in 3 cycles (2.48%) of gbs, ms, and aie patients, grade 3 urticaria in two cycles (1.65%) of gbs and patients with ms.Moreover, grade 2 hypertension, grade 1 dyspnea, and grade 1 nausea were observed in one cycle (0.83%) of aie, ms, and adem patients, respectively.One dose of hydrocortisone was injected iv to treat urticaria, and enalapril was used to control hypertension; none induced hemorrhage or infection.No mortalities were recorded during the process.Table 4 presents the improving effect of tpe on neurological exams.Neurological exams comprise items of color vision (cv), visual acuity (va), gag reflex, deep tendon reflexes (dtrs), glasgow coma scale (gcs), and muscle force.These exams were evaluated after a 5-10 day tpe course.Table 4 shows that in most cases, tpe significantly impacts patients with nmosd, aie, gbs, ms, and adem disorders.In contrast, tpe does not affect the visual acuity and color vision of optic neuritis patients, which may be due to the severity of damage to the optic nerve before performing the tpe.Discussion in this study, patients received a combination of ffp and 5% albumin throughout cycles.A patient developed tachycardia, hypertension, and chill simultaneously with symptoms of autonomic dysfunction during their disease.Therefore, it is challenging to understand if the hypotension was due to disease pathology or tpe.The most problematic cycles with several adverse effects, including chill and urticaria, were for a 73 kg 14-year-old girl in the ms subgroup, presumably because of being overweight (bmi = 26.8 kg/m2 -94% at risk).Furthermore, it can be related to a higher plasma dose, more plasma usage, and more susceptibility to allergy.The findings indicated that patients with ms experienced the most incidence of complications.In conclusion the findings of this investigation demonstrate that the tpe centrifugation technique is a practical and safe procedure in the pediatric age group.Additionally, the current study showed that a professional and experienced team could apply tpe as an efficacious therapeutic intervention.This method has minimal adverse effects on pediatric neuroimmunological disorders, even if used as the initial therapy.Complications are usually negligible and either easily correctable or self-limiting.Since this was a journal publication to evaluate the efficacy and safety of therapeutic plasma exchange in children with neuroimmunological disorders performed from march 2021 until april 2022, 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 (see below).No laboratory procedures are available to predict these reactions.Anaphylactic reactions, characterized by hypotension, tachycardia, nausea, vomiting and/or diarrhea, abdominal pain, severe dyspnea, pulmonary and/or laryngeal edema, and bronchospasm and/or laryngospasm, are rare (10/100,000 transfused units) but dangerous complications requiring immediate treatment with epinephrine.While these reactions have been reported in iga-deficient patients with anti-iga antibodies and patients with haptoglobin deficiency, most reactions are idiosyncratic and not associated with a specific serum protein deficiency, polymorphism, or identifiable cause.According to 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 according to the aabb circular of information for the use of human blood components (revised 2017), hypothermia carries a risk of cardiac arrhythmia or cardiac arrest and exacerbation of coagulopathy.Rapid infusion of large volumes of cold blood or blood components can depress body temperature, and the danger is compounded in patients experiencing shock or surgical or anesthetic manipulations that disrupt temperature regulation.A blood warming device should be considered if rapid infusion of blood or blood components is needed.Warming must be accomplished using an fda-cleared blood warming device so as not to cause hemolysis since this was a journal publication to evaluate the efficacy and safety of therapeutic plasma exchange in children with neuroimmunological disorders performed between from march 2021 until april 2022, the 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.Root cause: a root cause assessment was performed for the allergic reactions.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: * hypersensitivity to the ethylene oxide used to sterilize the disposable set.Hypersensitivity to the components inside the disposable set.Allergic reactions to the replacement fluids.Anaphylactic 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.Immediate hypersensitivity reaction (production of ige antibodies in response to allergens (plasma proteins in fresh frozen plasma).* passive sensitization (passive transfer of donor allergens or donor antibodies (e.G.Allergen-specific ige); transient allergic sensitivity to allergens.Patients underlying disease state or sensitivity to the apheresis procedure.A root cause assessment was performed for the hypertension.Based on the available information a definitive root cause could not be determined.Hypertension is a common side effect of therapeutic apheresis procedures.They are typically caused by the patient's disease state, 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 hypothermia.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 or comorbidities running a lengthy procedure without the use of a blood warmer replacement fluid was cold citation: nikkhah, a., nasehi, m.M., momtazmanesh, n., etemad, k., & hajatnia, s.(2024).Efficacy and safety of therapeutic plasma exchange in children with neuroimmunological disorders: a limited unicentral study.Pubmed, 18(2), 3141.Https://doi.Org/10.22037/ijcn.V18i1.40139.
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Event or Problem Description
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Per journal article, "efficacy and safety of therapeutic plasma exchange in children with neuroimmunological disorders: a limited unicentral study", by nikkhah, a., nasehi, m.M., momtazmanesh, n., etemad, k., & hajatnia, s., patients received therapeutic plasma exchange (tpe) with a combination of fresh frozen plasma (ffp) (80-20%) and 5% albumin with 5-10 cycles every other day.Patients with pulmonary non-infectious disease (pnid) received 121 tpe cycles.The present research investigated tpe-related complications in subgroups.Out of all the tpe cycles, three cycles (2.48%) in the autoimmune encephalitis (aie) subgroup, two (1.65%) in guillain-barre syndrome (gbs), five (4.13%) in multiple sclerosis (ms), and one (0.82%) in acute disseminated encephalomyelitis (adem), and no cycles in neuromyelitis optic spectrum disorder (nmosd) and optic neuritis (on) subgroups showed adverse effects.Grade 1 (as per ctcae) chill was observed in three cycles (2.48%) of ms and aie patients, grade 1 tachycardia in 3 cycles (2.48%) of gbs, ms, and aie patients, grade 3 urticaria in two cycles (1.65%) of gbs and patients with ms.Moreover, grade 2 hypertension, grade 1 dyspnea, and grade 1 nausea were observed in one cycle (0.83%) of aie, ms, and adem patients, respectively.One dose of hydrocortisone was injected iv to treat urticaria, and enalapril was used to control hypertension; none induced hemorrhage or infection.In this study, patients received a combination of ffp and 5% albumin throughout cycles.A patient developed tachycardia, hypertension, and chill simultaneously with symptoms of autonomic dysfunction during their disease.Therefore, it is challenging to understand if the hypotension was due to disease pathology or tpe.The most problematic cycles with several adverse effects, including chill and urticaria, were for a 73 kg 14-year-old girl in the ms subgroup, presumably because of being overweight (bmi = 26.8 kg/m2 -94% at risk).Furthermore, it can be related to a higher plasma dose, more plasma usage, and more susceptibility to allergy.The findings indicated that patients with ms experienced the most incidence of complications.Per the journal article the patient's adverse events were temporary and curable.No severe complications were observed, and tpe was generally well tolerated.No mortalities were recorded during the process.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.The platelet collection set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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