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 (b)(6) 2023 from a 79 year old female patient with a medical history including end stage renal disease, who stated she experienced shortness of breath when the device did not remove the programmed amount of fluid during treatment on (b)(6) 2023 and was admitted to hospital with fluid overload.Although requested, additional information regarding the event and hospitalization was not provided.
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