The customer reported that during a continuous mononuclear cell (cmnc) collection procedure, the patient remained hemodynamically stable.At the end of the procedure, the patient had some erythema.The patient told the doctor that she had the reddening skin during the procedure as well.During the procedure, the patient what appeared to be a mild citrate reaction, with tremors and cold, that did not require any medical intervention.24 hours after the procedure, the doctor reported that the patient had hyperemia, tachycardia, and high blood pressure.The symptoms presented were: tingling in the feet, tremors, diffuse erythema, sinus tachycardia, mild hypertension.There was no fever or respiratory changes.During the collection, calcium and magnesium replacement were performed.The attending physician said that the patient began to experience these reactions during collection and remained with erythema, tachycardia and hypertension until she visited and the doctor prescribed an antihistamine for her.The next day, the doctor said that the erythema has already improved.Per the customer, filgrastim 300 mcg 1 ampoule 12 / 12h was used from the 16th to the 20th of october plus plerixafor on the 19th of october was used for mobilization.Patient identifier, age, and weight are not available at this time.The disposable set is not available for return because it was discarded by the customer this product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Investigation : according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these 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.A disposable complaint history search for lot 1910313230 found no other reports of allergic reactions.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Sterilization and aeration were successfully completed.This product has been validated to achieve less than 6mg eto, meeting the requirements of iso 10993-7 prior to release and less then 1ppm in the collect bag at time of use.Investigation is in process.A follow up report will be provided.
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