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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A report was received on (b)(6) 2022 from the home therapy nurse (htn) of a (b)(6) female patient with a medical history including end stage renal disease, who stated an insufficient amount of programmed fluid was removed during home hemodialysis treatments, most recently on (b)(6) 2022.Per the htn, the patient has been progressively fluid overloaded since late on (b)(6) 2021 without a differential causal diagnosis provided.Additional information was received on 01 apr 2022 from the (htn) who stated the patient has developed cardiac issues (nos) related to fluid overload, has had pitting edema on her lower legs, possible abdominal fluid retention, with a planned procedure to remove thoracic fluid buildup (thoracentesis).Although the cause of the fluid overload has not been determined, a possible relationship to the device cannot be excluded.
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