MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Model Number NX1000-16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Convulsion/Seizure (4406); Speech Disorder (4415)

Event Date 09/04/2023

Event Type  Injury  

Manufacturer Narrative

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 outlines risks associated with performing hemodialysis therapy and warns all treatments must be administered under a physician's prescription and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.Udi: (b)(4).

Event Description

A report was received on (b)(6) 2023 from the caregiver of a 72 year old male patient with a medical history including history of stroke and end stage renal disease, who stated the patient experienced an adverse event two hours into a home hemodialysis treatment on (b)(6) 2023.Additional information was received on (b)(6) 2023 from the home therapy nurse (htn), who stated the symptoms included a sudden decline of blood pressure (values not provided), vomiting, slurred speech and a seizure.Emergency medical services (ems) were called, and per the htn the patient was admitted with a diagnosis of hypertension.While at the hospital, the patient''s blood pressure returned to normal (nos), and the computed tomography (ct) scan was negative.No further details of the hospitalization or discharge date were provided and the htn stated the plan following discharge involved resuming therapy with the nxstage system.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• Manufacturer (Section G): MEDIMEXICO S. DE R. L. DE C. V; av. valle imperial no. 10523; parque industrial valle sur; tijuana 22180 ; MX 22180
• Manufacturer Contact: paula rogalski ; nxstage medical, inc.; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 17804290
• MDR Text Key: 324111566
• Report Number: 3003464075-2023-00075
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-16
• Device Catalogue Number: CYCLER VERSIHD 1.0, NO NIBP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male