| Catalog Number 10220 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Atrial Fibrillation (1729); Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Nausea (1970)
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| Event Date 04/15/2023 |
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Event Type
Injury
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Event Description
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Per journal article "indications and outcomes of patients receiving therapeutic plasma exchange under critical care conditions: a retrospective eleven-year single-center study at a tertiary care center journal of clinical medicine, 12(8), #pages#" by, ring, a.,sieber, w.A.,studt, j.D.,schuepbach, r.A.,ganter, c.C.,manz, m.G.,müller, a.M.S.,david, s.(2023 therapeutic plasma exchange (tpe) is frequently performed in critical care settings for heterogenous indications.However, specific intensive care unit (icu) data regarding tpe indications, patient characteristics and technical details are sparse.Methods: we performed a retrospective, single-center study using data from january 2010 until august 2021 for patients treated with tpe in an icu setting at the university hospital zurich.Data collected included patient characteristics and outcomes, icu-specific parameters, as well as apheresis-specific technical parameters and complications.Results: we identified n = 105 patients receiving n = 408 tpes for n = 24 indications during the study period.The most common was thrombotic microangiopathies (tma) (38%), transplant-associated complications (16.3%) and vasculitis (14%).One-third of indications (35.2%) could not be classified according to asfa.Anaphylaxis was the most common tpe-related complication (6.7%), while bleeding complications were rare (1%).The median duration of icu stay was 8 - 14 days.Ventilator support, renal replacement therapy or vasopressors were required in 59 (56.2%), 26 (24.8%), and 35 (33.3%) patients, respectively, and 6 (5.7%) patients required extracorporeal membrane oxygenation.The overall hospital survival rate was 88.6%.Conclusion: our study provides valuable real-world data on heterogenous tpe indications for patients in the icu setting, potentially supporting decision-making.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 collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.Ring, a., sieber, w. a., studt, j., schuepbach, r. a., ganter, c. c., manz, m. g., müller, a. m., & david, s.(2023).Indications and outcomes of patients receiving therapeutic plasma exchange under critical care conditions: a retrospective eleven-year single-center study at a tertiary care center. journal of clinical medicine, 12(8), 2876. https://doi.Org/10.3390/jcm12082876.
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Event Description
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Per journal article "indications and outcomes of patients receiving therapeutic plasma exchange under critical care conditions: a retrospective eleven-year single-center study at a tertiary care center journal of clinical medicine, 12(8), #pages#" by, ring, a.,sieber, w.A.,studt, j.D.,schuepbach, r.A.,ganter, c.C.,manz, m.G.,müller, a.M.S.,david, s.(2023 therapeutic plasma exchange (tpe) is frequently performed in critical care settings for heterogenous indications.However, specific intensive care unit (icu) data regarding tpe indications, patient characteristics and technical details are sparse.Methods: we performed a retrospective, single-center study using data from january 2010 until august 2021 for patients treated with tpe in an icu setting at the university hospital zurich.Data collected included patient characteristics and outcomes, icu-specific parameters, as well as apheresis-specific technical parameters and complications.Results: we identified n = 105 patients receiving n = 408 tpes for n = 24 indications during the study period.The most common was thrombotic microangiopathies (tma) (38%), transplant-associated complications (16.3%) and vasculitis (14%).One-third of indications (35.2%) could not be classified according to asfa.Anaphylaxis was the most common tpe-related complication (6.7%), while bleeding complications were rare (1%).The median duration of icu stay was 8 - 14 days.Ventilator support, renal replacement therapy or vasopressors were required in 59 (56.2%), 26 (24.8%), and 35 (33.3%) patients, respectively, and 6 (5.7%) patients required extracorporeal membrane oxygenation.The overall hospital survival rate was 88.6%.Conclusion: our study provides valuable real-world data on heterogenous tpe indications for patients in the icu setting, potentially supporting decision-making.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.This journal contains information of a patient death, per confirmation of the article there is not allegation of terumo bct involvement.The collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: we performed a retrospective, single-center study using data from january 2010 through september 2021 of consecutive patients treated with tpe at the institute of intensive care medicine (6 units, 72 beds total capacity) at the university hospital zurich (usz).The key aim of our study was to analyze indications, technical details as well as patient and icu-specific parameters.Patients were identified from our electronic health record system (klinikinformationssystem kisim) using specific search terms: ¿plasmapheresis¿, ¿plasma exchange¿ and/or ¿pex¿.We included all patients aged_ 18 years treated for any indication of tpe in the icu setting.Recorded and analyzed variables included patient socio-demographic data (age and gender), bmi, underlying disease (according to asfa classification), major comorbidities, laboratory parameters, icu-specific data (sequential organ failure assessment (sofa) score, mechanical support (renal, ventilatory, circulatory), vasoactive-inotropic treatment, duration of icu stay, hospital survival) and tpe-specific procedural parameters (number of tpe sessions, type and amount of replacement fluids, vascular access and complications).Apheresis was performed in collaboration with the department of medical oncology and hematology using the cobe spectra or spectra optia apheresis system (terumo, tokyo, japan), which applies continuous-flow centrifugation for the separation of cellular components from plasma.Plasma volumes were calculated using each patient¿s weight and hematocrit value.Regional citrate anticoagulation was used in all cases.3.4.Tpe procedural details and level of evidence during the 11-year observation period, 408 tpe sessions (mean of 3.9 + 3.3 per patient) were performed in the icu setting (table 2), representing 10.2% of all tpes at the usz during the study period (n = 4008).Figure 2a,b show the total number (a) and mean number (b) of tpe sessions for all indications.Patients presenting ttp were exchanged up to 19 times (figure 2a) with a mean of 3.8 + 4.2 session) (figure 2b).Tpe for tpa was discontinued after thrombocyte count reached >150 g/l.The highest mean number of tpe sessions was documented for goodpasture¿s syndrome (7 + 5.3) (figure 2a,b).Autoimmune-related diseases were exchanged every 2¿3 days to allow transfer of igg from tissues and subsequent removal from the bloodstream.The average number of sessions did not vary significantly between indications with clear asfa recommendations (category i or iii) and variable or no clear guideline-based indication (p = 0.226, mann¿whitney test) (figure 2c).Figure 3 summarizes the number of patients, mean tpe session count and asfa category and grade of recommendation for each indication.The mean amount of replacement fluid was 3.4 + 0.85 l per session, the type of replacement fluid was fresh frozen plasma (ffp) in 84 (80%) patients, human albumin in 13 (12.4%) patients and a mixture of both in five (4.8%) patients (table 5).Three patient records (2.9%) did not specify the replacement fluid used.Most patients (n = 97, 92.4%) received a central vascular catheter for tpe and five (4.8%) had peripheral venous access (table 5).Three (2.8%) had incomplete records.Complications occurred in 10 (9.5%) patients and were mostly mild to moderate transfusion-related allergic reactions (grade 1 n = 4, 3.8%; grade 2 n = 3, 2.9%) that responded well to guideline confirm treatment (table 5).Grade 1 represents reactions where symptoms either presented cutaneous, conjunctival, in the upper respiratory tract or others like nausea and metallic taste.The allergic reaction is classified as grade 2 when >2 of the organ systems listed in grade 1 are affected or if there are gastrointestinal symptoms present.More severe complications occurred in three patients (2.9%) (table 5).One patient with progressive bulbar palsy suffered repeat bleeding while receiving human albumin and required substitution of fibrinogen, cryo-precipitated factor concentrates and factor xiii.After switching the replacement fluid to ffp no further complications occurred.Another patient with ttp went into cardiac arrest and died during tpe.An autopsy revealed massive thrombi in both ventricles.The third patient developed atrial fibrillation, which was successfully treated with cardioversion.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.According to therapeutic apheresis: a physician's handbook, when plasma is exchanged with a non plasma replacement solution, coagulopathy caused by dilution of coagulation factors is a potential problem.The prothrombin time and activated partial thromboplastin time rise and fibrinogen falls to an extent related to the intensity of the exchange.Despite these hemostatic alterations, hemorrhagic complications of dilutional coagulopathy are seldom encountered unless a patient is hemostatically compromised before treatment.Routine supplementation of replacement fluids with plasma or other sources of clotting factors is not recommended for nonbleeding patients whose baseline coagulation is normal.Redistribution and ongoing synthesis raise levels of most coagulation factors rapidly in the hours following an exchange.Fibrinogen is usually replaced more slowly and might be considered the rate-limiting factor determining the frequency of procedures performed without replacement of coagulation factors.However, the production of this acute-phase protein varies greatly among patients.Fibrinogen levels may decrease somewhat below 100 mg/dl if several procedures are performed on consecutive days.A level near 100 mg/ml is generally sufficient for hemostasis unless the individual has another hemostatic challenge.If fibrinogen decreases a great deal below 100 mg/dl, some physicians will then increase the interval between procedures or will use plasma replacement during the last part of the procedure to avoid a potential bleeding diathesis.18 fresh frozen plasma (ffp) is the preferred source of fibrinogen, and it supplies other coagulation factors as well.Ffp is seldom required, though, if tpe is performed at intervals of 72 hours or greater.Hemorrhage is rarely reported in patients undergoing a tpe series without plasma replacement if there is no underlying predisposition to bleeding.According to therapeutic apheresis: a physician's handbook, morbidity and mortality related to therapeutic procedures are greater in acutely ill patients treated in a hospital setting than in "routine" patients treated in an outpatient setting.No fatalities were attributed to apheresis during 20,485 procedures reported from the swedish registry.The french apheresis registry calculated an overall mortality between 1/10,000 and 2/10,000.A patient's death during an apheresis series is most often attributed to the underlying disease and is rarely directly related to the procedure.There is no evidence to indicate that the optia device caused or contributed to the patient¿s death.Therefore, there is no failure mode or associated risk that can be evaluated for spectra optia.According to adverse events in apheresis: an update of the world apheresis association registry data (henriksson, et al), more aes occurred during the first procedures versus subsequent (8.4 and 5.5%, respectively).Aes were mild in 2.4% (due to access 54%, device 7%, hypotension 15%, tingling 8%), moderate in 3% (tingling 58%, urticaria 15%, hypotension 10%, nausea 3%), and severe in 0.4% of procedures (syncope/hypotension 32%, urticaria 17%, chills/fever 8%, arrhythmia/asystole 4.5%, nausea/vomiting 4%).3 severe arrhythmia in 10,000 procedures may be expected to appear with plasma as replacement fluid compared to 1 severe arrhythmia in 10,000 procedures where albumin is used for plasma exchange with centrifugation technique.1 mild arrhythmia in 10,000 procedures may be expected to appear with plasma as replacement fluid and 1 mild arrhythmia in 10,000 procedures where albumin is used.This was a journal publication presenting data of a retrospective, single-center study using data from january 2010 until august 2021 for patients treated with tpe using spectra optia in an icu setting at the university hospital zurich.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.Root cause: a root cause assessment was performed for the reported transfusion related allergic reactions.According to the authors, the patients were allergic to the replacement fluids used in the tpe procedure.A root cause assessment was performed for the reported bleeding.According to the authors, ¿one patient with progressive bulbar palsy suffered repeat bleeding while receiving human albumin and required substitution of fibrinogen, cryo-precipitated factor concentrates and factor xiii.After switching the replacement fluid to ffp no further complications occurred.¿ a root cause assessment was performed for the reported death.According to the authors, ¿another patient with ttp went into cardiac arrest and died during tpe.An autopsy revealed massive thrombi in both ventricles.¿ a root cause assessment was performed for the atrial fibrillation.Based on the available information a definitive root cause could not be determined.Atrial fibrillation 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.Citation: ring, a., sieber, w. a., studt, j., schuepbach, r. a., ganter, c. c., manz, m. g., müller, a. m., & david, s.(2023).Indications and outcomes of patients receiving therapeutic plasma exchange under critical care conditions: a retrospective eleven-year single-center study at a tertiary care center. journal of clinical medicine, 12(8), 2876. https://doi.Org/10.3390/jcm12082876.
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