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

Model Number NX1000-3

Device Problem Insufficient Information (3190)

Patient Problem Respiratory Distress (2045)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

The cycler was returned for investigation and passed all testing.The cycler was performing as designed and intended.A device history record (dhr) review was conducted for the cycler which met all manufacturing requirements and specifications prior to release of the unit.A cartridge dhr review showed there were no related issues and no quality issues found during the manufacture of this lot.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.Udi number (b)(4).

Event Description

A report was received on (b)(6) 2017 from the caregiver of a (b)(6) male patient who stated the patient reported shortness of breath following a standard hemodialysis treatment on (b)(6) 2017.The patient was hospitalized on (b)(6) 2017 and received hemodialysis to remove excess fluid.Additional information received on august 4, 2017 from the director of home therapies at the facility, stated the hospitalization for fluid removal was related to patients non-compliance and unrelated to nxstage products or therapy.Follow-up information received on august 10, 2017 from the staff at the facility indicated that the patient was released from hospital on (b)(6) 2017 and is continuing standard home hemodialysis without issue.The patient's comorbidities included end stage renal disease, hypertension, hyperlipidemia, and type ii diabetes mellitus.Despite the patient¿s comorbidities a relationship to nxstage products could not be ruled out by the patient¿s physician.

• 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 ; 9786874700
• MDR Report Key: 6835576
• MDR Text Key: 84267489
• Report Number: 3003464075-2017-00042
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/31/2017

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: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• 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: 54 YR
• Patient Weight: 121