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Model Number NX1000-1 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Hypovolemia (2243)
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Event Date 12/13/2022 |
Event Type
Injury
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Event Description
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A report was received on 20 dec 2022 from the caregiver of a 67 year old male patient with a medical history including end stage renal disease, who stated an excessive amount of programmed fluid was removed during a home hemodialysis treatment on (b)(6) 2022.The patient experienced decreased blood pressure (58/40 mmhg) and had to go to hospital.Additional information was received on 22 dec 2022 from the health care processional (hcp) who stated the patient also experienced chest pain, breathlessness, and dizziness and was admitted (b)(6) 2022.The patient received unspecified fluids, and was discharged the following day, (b)(6) 2022, with instructions to increase their target dry weight.Following the event the patient has recovered without sequelae and resumed treatment with the nxstage system.
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Manufacturer Narrative
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The involved cycler was not received for evaluation.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 provides information on the risks associated with dialysis therapy and suggested actions, instructions, cautions and warnings to enable patients to treat safely and effectively.
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Search Alerts/Recalls
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