The device was received for evaluation and successfully passed the prime and alarms test confirming proper functionality of the device and sensors.Available log files were retrieved and analyzed which showed device performance was without incident and was unremarkable.A review of the device history record confirmed the product was released meeting all product design specifications and quality criteria.All information supports the device was functioning as designed and intended with no malfunction.The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.(b)(4).
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A report was received on 25 feb 2021 from the home therapy nurse (htn) of an (b)(6) male patient with a medical history of multiple comorbidities and end stage renal disease, approved for performing solo home hemodialysis therapy, stating the patient was found unresponsive on (b)(6) 2021.Additional information was received on 26 feb 2021 from the htn who stated that emergency services were contacted and the patient was pronounced on scene.Per the htn, the available treatment information was unremarkable and the medical doctor suspects the cause of death to be cardiopulmonary arrest unrelated to nxstage product or therapy.
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