A report was received on (b)(6) 2022 from the caregiver of a (b)(6) female patient with a medical history including end stage renal disease, who stated insufficient fluid was removed during recent hemodialysis treatments and the patient went to hospital because they were over their dry weight.Although requested, additional information regarding the hospital visit was not provided.
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The involved cycler was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed the device met all quality criteria and manufacturing specifications prior to release.Factors outside the scope of nxstage therapy can impact the patient's weight, these include but are not limited to the accuracy with which intake is recorded, the weighing techniques used, and the patient's comorbidities.The nxstage system one user guide provides information on the risks associated with dialysis therapy and suggested actions, instructions, cautions and warnings to enable patients to treat safely and effectively.Udi: (b)(4).
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