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

Model Number NX1000-3

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

Patient Problems Aortic Valve Stenosis (1717); Fatigue (1849); Pulmonary Edema (2020); Weakness (2145)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

The cycler has not been received for evaluation.A device history record (dhr) review was conducted for the cycler which revealed the device met all manufacturing requirements and specifications prior to release of the unit.The user guide warns that the patient should follow the physician's prescription and that the patient must be closely monitored for signs and symptoms of excessive ultrafiltration or fluid overload.Udi #: (b)(4).Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on 25 feb 2019 from the caregiver of an (b)(6) female with medical history significant for an internal pacemaker, aortic stenosis, congestive heart failure (chf), atrial fibrillation and diastolic heart failure who stated the patient was hospitalized following hemodialysis therapy where the programed amount of fluid was not removed on (b)(6) 2019.Additional information received on (b)(6) 2019 from the home therapy nurse (htn) revealed that the patient presented to hospital and was admitted with generalized weakness and fatigue on (b)(6) 2019, two days after the most recent hemodialysis therapy.Evaluation and treatment in hospital included a chest x-ray showing mild pulmonary edema, an echocardiogram showing worsened aortic stenosis and hemodialysis therapy.The htn stated the patient was non-compliant with her dietary fluid restrictions and had performed less treatments than prescribed in the week prior to hospitalization.The patient was discharged on (b)(6) 2019 in stable condition and continues to treat using the nxstage system one.

• 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: 8447605
• MDR Text Key: 139694490
• Report Number: 3003464075-2019-00009
• Device Sequence Number: 0
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR