Model Number NX1000-1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Low Blood Pressure/ Hypotension (1914); Chills (2191); Convulsion/Seizure (4406)
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Event Date 02/03/2021 |
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 03 feb 2021 from the home therapy nurse (htn) of a (b)(6) female with a medical history including end stage renal disease and coagulation defect, stating the patient expired during a hemodialysis session on (b)(6) 2021.Additional information was received on 05 feb 2021 from the htn, who stated that the patient experienced chills, decreased blood pressure and seizure prior to absence of vital signs.Per the htn, no medical intervention was provided, and the cause of death is unknown.
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Event Description
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Additional information was received from the htn on (b)(6) 2021 indicating the patient became symptomatic while disconnecting from the device.Per the htn, emergency services resuscitation efforts were unsuccessful, and the patient expired.No cause of death was provided.
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Manufacturer Narrative
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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.All information supports the device was functioning as designed and intended with no malfunction.
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Search Alerts/Recalls
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