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Lot number and expiry information are not available at this time.Investigation: per the article, there were four technical errors detected.Three involved centrifugation sets manufacturing defects, and one involved error in centrifugation set installation.Adverse events were graded according grading adapted from the swedish apheresis group.Adverse events were graded as mild (grade i) in 5.3% (13/245), moderate (grade ii) in 2.0% (5/245) and severe (grade iii) in 2.0% (5/245).Grade i requires no medical intervention.All vascular accesses were by a temporary double lumen central venous catheter.In kilograms.Patients were pre-loaded with 500 ml of normal saline to ensure adequate hydration and volume before each procedure.The blood pump speed was set between 40 and 120 ml/min.Intravenous 1 g calcium gluconate was infused during tpe as standard protocol.Replacement fluids were 2/3 albumin 5% in hartmann¿s solution and remaining 1/3 with normal saline crystalloids solution.Vital signs monitoring every 15 min during the procedures with a cardiac monitoring were performed as standard observation protocol (15¿30 min intervals).All patients had internal jugular catheter inserted for tpe under ultrasound guidance.Symptomatic hypocalcemia associated with the acid-citrate-dextrose solution use was observed in 5 of the patients, while allergic reactions associated with the use of transfused human albumin such as rashes and nausea were reported in 1 patient.There was no potentially life-threatening complications or procedure-related mortality occurring among our cohort of patients.Four incidences involving technical errors were noted by tpe staffs while performing the procedures; three were due to centrifugation set manufacturing defects, resulting in inability to initiate procedures (two sets) and procedure termination due to high pressure error (one set).Another technical glitch was due to error in centrifugation set installation onto the machine.The high centrifugation frequency resulted in a crack at the tubing set, with subsequent blood leak and visible contamination in the rotating separation chamber.No report of adverse event affecting the patient was noted.They performed further pearson¿s correlation analysis to search for associations of tpe complications with procedure parameters (baseline weight, pre-procedure hct, number of tpe cycles and exchanged pv).They found only higher pv exchange was significantly associated with crbsi (p=0.023).Although the exchanged pv was based on formula calculated with patient¿s body weight and pre-procedure hct, both parameters were not independently a factor for higher infection risk.Similarly, we found no different in average hct among the group of patients who developed hypotension and those who did not (37% vs 37%, p=0.889).Number of tpe cycles was not associated with the incidence of infection.No tpe parameter was found to be associated with hypotension, hypocalcaemia and allergic reaction.However, we experienced slightly higher rates of hypotension (4.9%) secondary to fluid shift compared with the reported rates at 0.4%¿4.2%.This could be attributed to the use of a less vascular expansion fluid replacement regime of human albumin 70% and crystalloids 30% compared with 100% human albumin.Majority of the hypotensive events were handled by reducing inlet flow rates and infusion of crystalloid saline.Article citation: fu ks, wong py, hiew fl.Therapeutic plasma exchange (tpe) for semi- critical neurology presentations in a non- acute neurology set- up: clinical practice and challenges.Bmj neurology open 2020;2:e000020.Doi:10.1136/ bmjno-2019-000020 investigation is in process.A follow-up report will be provided.
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Per the article, 'therapeutic plasma exchange (tpe) for semi- critical neurology presentations in a non- acute neurology set- up: clinical practice and challenges' in bmj neurology open by fu et al, both adverse events and "technical errors" are described, which occurred during therapeutic plasma exchange (tpe) procedures with spectra optia.The study was performed between may 2015 and june 2018.A total of 245 tpe procedures were performed in 55 patients for nine neurological indications, predominantly the central nervous system (79%).There were 16 (29%) men and 39 (71%) women with median age of 41 years old (range 13¿63).The median weight of patients was 56 kg there were five moderate (intervention required; treatment completed) adverse reactions and five severe (procedure interrupted or abandoned) adverse reactions.Hypotensive episodes during tpe were the most commonly reported events.All patients responded to either with reduction of inlet flow rates, intravenous hydration, or cessation of tpe procedure.One event required commencement of intravenous infusion of vasopressors.Hypocalcemia and allergic reactions were also reported.Exact patient data, outcomes, and any treatment for reactions is not provided in the article, therefore this report is being filed as a summary of the 10 reported patient reactions.The disposable set is not available for return because it was discarded by the customer.
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This report is being filed to provide additional information in b.5, e.1, e.3, h6 & h10.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The authors concluded performing tpe in a non-acute set-up by trained neurology nurses proved safe, with low rates of complications comparable with other established centres.Although rare, occurrence of several technical errors and adverse effects that have not significantly improved over time require further quality improvement including staff training, treatment protocol revision and establishment of a more robust tpe registry.Important aspects of improvement should focus on enhancement of theoretical knowledge and practical experience, recognising complications and initiation of appropriate measures.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.Adverse effects related to vascular access are a frequent concern.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.During a dressing change, the site should be cleaned and observed for signs of infection such as redness, swelling, drainage, and foul odor.If an infection is suspected, cvc removal should be considered, and the patient should be treated for infection as appropriate.The cause of a cvc flow problem may sometimes be difficult to determine, although patient repositioning will sometimes improve flow.A common situation is that the cvc can be flushed without resistance but does not yield blood return; this scenario may be the result of kinking, poor positioning, intralumenal clots, or venous thrombosis.Blocked cvcs can sometimes be cleared with a fibrinolytic agent such as tpa.The placement of a cvc is considered by some to be the greatest risk related to the apheresis procedures, and it should be avoided if the procedure can be performed using peripheral iv root cause: a definitive root cause for the reported patient reactions could not be determined.The authors concluded no tpe parameter was found to be associated with the reports of hypotension, hypocalcemia, and allergic reaction.Possible causes for citrate reactions include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.Possible causes for allergic reactions include but are not limited to replacement fluid (human albumin), concurrent medications, or ethylene oxide from sterilization processes.Possible causes for vasovagal reactions include but are not limited to patient disease state and/or patient sensitivity to the procedure.The root cause for the crbsis, beyond catheter association, could not be determined.Possible causes for the high centrifuge pressure alarm include, but are not limited to: - air in ac line entered channel - channel was not correctly loaded - inlet access was not securely connected - tubing set was defective - pressure sensor was uncalibrated/defective the root cause for the disposable kit misload was operator error.
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