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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A report was received on 08 feb 2024 from the nurse of a 55 year old male patient with a complex medical history including end stage renal disease, who stated an insufficient amount of programmed fluid was removed during hemodialysis treatment and the patient was hospitalized on (b)(6) 2024.Additional information was received on 14 feb 2024 from home therapy nurse (htn) who stated the patient presented to the emergency department on (b)(6) 2024 with high blood pressure (197/94 mmhg), pulmonary edema, and shortness of breath.The patient was admitted and received hemodialysis therapy and intravenous furosemide (lasix) 100mg.The patient recovered without sequelae and was discharged (b)(6) 2024.Following the event the patient continues to treat using the nxstage system.
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