A patient in (b)(6) who had been diagnosed with a transplant rejection underwent therapeutic plasma exchange (tpe) treatment.At the initiation of the tpe treatment, the patient complained of back pain, nausea and malaise.The tpe treatment was temporarily suspended and the patient was administered analgesics and antihistamines; the treatment was then continued and completed as intended.During the investigation of this event, the customer indicated the patient may have suffered from hemolysis but this was never confirmed.
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