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

Model Number NX1000-1

Device Problem Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Seizures (2063)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for investigation.A review of the device history record (dhr) for the device was reviewed and no manufacturing or service issues were noted related to the reported event.Review of the treatment details revealed that an estimated 110ml of rinseback volume had not been removed by the user.The nxstage system one user guide provides instructions for removing rinseback volume using automated device settings, and warns that some patients such as low weight patients may be unable to tolerate small fluid balance changes.The care partner has been retrained in device settings and the calculation of rinseback volume.(b)(4).

Event Description

A report was received on (b)(6) 2018 from a home therapy nurse regarding a (b)(6)-year-old male with multiple comorbidities including a history of seizures, hypertension and blood pressure fluctuations, who experienced seizure-like activity and hypertension after a standard home hemodialysis treatment on (b)(6) 2018 and was admitted to the hospital.Treatment included a clonidine patch (nos weekly), hydralazine (nos prn) and hemodialysis, and he was discharged on (b)(6) 2018.

• 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: 7534683
• MDR Text Key: 108976983
• Report Number: 3003464075-2018-00024
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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: 7 YR
• Patient Weight: 20