As reported by the user facility: patient had an adverse reaction upon starting dialysis with a diacap pro 19h filter.Approximately three (3) minutes after being connected to the machine the patient experienced a racing heart, tingling sensation to the jaw diaphoretic, blood pressure dropped suddenly and the patient became unresponsive.The treatment was immediately discontinued.The patient was treated by the code blue team according to the hospital's protocol.The patient was admitted to the hospital and had dialysis treatment the following day with a different dialyzer brand with no issues.
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Exemption number e2015011.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum saxonia gmbh (manufacturer).This report has been identified as b.Braun avitum internal report # (b)(4).Two (2) unused dialyzers of batch 121880917 were returned for investigation.The investigation of the returned samples did not show any product deviation.The review of the device history record of the fiber and the dialyzer, as well as of the incoming inspection certificates of the materials in contact with the blood (potting material, blood caps, sealing rings), did not show any deviation.The biocompatibility of all components of the diacap pro dialyzers, as well as the finished product, is tested according to din en iso 10993.The review of the complaint database shows four (4) cases during the last three (3) years reporting that patients developed symptoms during a therapy with a diacap pro dialyzer.In none of these cases was there a product deviation.Batch 121880917 was manufactured in september 2017 and no other complaints were reported against this batch.It is known that hypersensitive reactions may occur on rare occassions during the use of dialyzers.The instructions for use of the diacap pro informs about potential side effects as follows: hypersensitivity reactoins may occur in rare cases during dialysis.If hypersensitivity reactions are severe, the dialysis must be discontinued and appropriate medical treatment should be initiated.The blood from the extracorporeal system must not be returned to the patient.Diacap pro dialyzers are gamma sterilized in an oxygen-free environment and do not contain any sterilization residuals.The medical assessment of the current case by a nephrologist indicate that the described symptoms are compatible with such a hypersensitive reaction.Although there is no evidence of product deviation, the manufacturer is conducting additional investigations regarding the patients having symptoms during therapy.If additional pertinent information becomes available a follow-up report will be filed.Correction: the manufacturer address was corrected in section d3 and g1-2.The address was corrected to: (b)(4).
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As reported by the user facility: patient had an adverse reaction upon starting dialysis with a diacap pro 19h filter.Approximately three (3) minutes after being connected to the machine the patient experienced a racing heart, tingling sensation to the jaw diaphoretic, blood pressure dropped suddenly and the patient became unresponsive.The treatment was immediately discontinued.The patient was treated by the code blue team according to the hospital's protocol.The patient was admitted to the hospital and had dialysis treatment the following day with a diferent dialyzer brand with no issues.
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