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

Model Number NX1000-3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Injury (2348)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

The cycler was not provided 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.Factors outside the scope of nxstage can contribute to fluid overload.Udi: (b)(4).Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on 26 dec 2018 from the caregiver of a (b)(6) male with a history of clinical and hemodynamic instability, morbid obesity, hypotension, diabetes, multiple cardiac surgeries, a history of dehydration as well as fluid overload, who was hospitalized with fluid overload (nos) following a standard home hemodialysis treatment on (b)(6) 2018.While hospitalized he received unspecified treatment for fluid overload and was discharged on (b)(6) 2018.The nurse stated there were multiple potential causes including the patient's diet and sodium intake that could contribute to the fluid overload.A discharge summary was requested but has not been received.

• 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: 8256861
• MDR Text Key: 133360714
• Report Number: 3003464075-2019-00002
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 138