During treatment of a patient with a prismaflex tpe2000 set, during the infusion of the first fresh frozen plasma bag, the patient had severe lumbar pain (visual analogue scale pain at 10/10), that radiated to the hips and buttocks.Exchange was interrupted for 25 minutes, and the patient received 1 g of paracetamol and 3 mg of morphine (route of administration not reported).The outcome of the patient was not reported.No additional information is available.
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Additional information: the treatment was restarted after 25 min with the same set and no plasma exchange.The device was not received for evaluation; therefore, a device analysis could not be completed a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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