The device was received for evaluation and successfully passed testing.Available log files were retrieved and analyzed which showed the cycler performed as intended and alarmed appropriately when the alarm conditions were present.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.The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.Udi: (b)(4).
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A report was received on 06 aug 2021 from the home therapy nurse (htn) of a (b)(6) male with a medical history including hypertension and end stage renal disease approved for performing solo home hemodialysis treatment, who stated the patient expired at an unspecified time during a home hemodialysis treatment on (b)(6) 2021.Additional information was received on 06 aug 2021 from the htn who stated the patient was found unresponsive at 7:40 by his son.911 was called and emergency services performed cardiopulmonary resuscitation (cpr) before the patient was pronounced at the scene.Per the htn and physician, the patent's death is due to a sudden cardiac event, unrelated to nxstage product or therapy.
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