Model Number NX1000-3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 02/16/2021 |
Event Type
Death
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Manufacturer Narrative
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The involved device was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.Based on the available information, there is no evidence to indicate that a malfunction occurred.A search of the complaint database revealed no other serious events associated with this device.(b)(4).
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Event Description
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A report was received on 17 feb 2021 from the home therapy nurse (htn) of a (b)(6) year old male patient with a medical history including hypertension and end stage renal disease, stating the patient expired while performing a home hemodialysis treatment at night without a care partner present on (b)(6) 2021.Additional information was received on 17 feb 2021 from the htn, who stated that the available treatment information was unremarkable, and an unspecified amount of blood was found at the scene.Per the htn the cause of death is unknown.
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Manufacturer Narrative
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The purpose of the supplemental report is to clarify that the mdr submitted is not the subject of an approved exemption and therefore number ¿5645646¿ included in the ¿exemption number¿ field was submitted in error.
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Manufacturer Narrative
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The device was received for evaluation and successfully passed testing, 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.All information supports the device was functioning as designed and intended with no malfunction.Udi: (b)(4).
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Search Alerts/Recalls
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