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

Model Number NX1000-3-A

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

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Renal Failure (2041)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

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. Factors outside the scope of nxstage therapy can impact the patient''s electrolytes, these include but are not limited to dietary and supplemental intake and the patient's comorbidities. The user guide (ug) warns "appropriate monitoring of the patient¿s hemodynamic, fluid, electrolyte, and acid-base balance should be performed regularly, per physician orders, to ensure appropriate response to therapy". (b)(4).

Event Description

A report was received on 16 oct 2021 from the home therapy nurse (htn) of a (b)(6)-year-old male patient with a medical history including multiple comorbidities and end stage renal disease, who stated that the patient experienced headache and hypertension (systolic in 220s mmhg) and required hospitalization following hemodialysis treatment on (b)(6) 2021. Additional information was received on 22 oct 2021 from the htn stating that the patient was admitted to hospital (b)(6) 2021 with a diagnosis of uncontrolled hypertension, headache, acute on chronic renal failure and hyperkalemia (7. 1 mmol/l). Hospitalization included pharmacologic intervention (sodium bicarbonate, calcium gluconate, insulin and glucose) and dialysis therapy with stabilization of the patient¿s laboratory values and vital signs. Over the counter supplements containing potassium were discontinued and the patient recovered without sequelae. The patient was discharged on (b)(6) 2021 to continue hemodialysis therapy using 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
• MDR Report Key: 12736837
• MDR Text Key: 279775556
• Report Number: 3003464075-2021-00062
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NX1000-3-A
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER, ROHS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/02/2021 Patient Sequence Number: 1