A report was received on 30 jan 2024 from the caregiver a 51 year old female patient with a complex medical history including end stage renal disease, who stated an insufficient amount of programmed fluid was removed during a home hemodialysis treatment on 29 jan 2024.The patient was admitted to hospital for fluid overload on (b)(6) 2024.Additional information was received on 07 feb 2024 from the home therapy nurse (htn) who stated the patient had experienced a progressively worsening cough, shortness of breath, and fluid overload.They were admitted for hemodialysis treatments and electrolyte replacement.Symptoms resolved and the patient was discharged on (b)(6) 2024 to continue home hemodialysis treatments using the nxstage system.
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A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.There was no indication of a device malfunction from the available information.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 outlines risks associated with performing hemodialysis therapy and warns all treatments must be administered under a physician's prescription and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.Udi: (b)(4).
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