(b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported that upon connection of a patient to a prismaflex m100 set for continuous renal replacement therapy (crrt) in the intensive care unit (icu), the patient suffered from a severe allergic reaction, further described as edema and tachycardia.The treatment was immediately discontinued due to the patient¿s symptoms and the patient was given 3 mg fenistil and 500 mg solu cortef (route of administration unknown).This was reported to be the patient's first crrt treatment.The patient was reported to have recovered from the allergic episode.No additional information is available.
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