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

Model Number NX1000-3

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Edema (1820); Weight Changes (2607)

Event Date 03/12/2019

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.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 13 mar 2019 from a (b)(6) female with unknown comorbidities who stated she was hospitalized with weight gain and edema following hemodialysis therapy where the programmed amount of fluid was not removed on (b)(6) 2019.Additional information received on (b)(6) 2019 revealed that the patient was hospitalized (dates not provided) and received unspecified treatment to remove excess fluid.She was subsequently discharged in stable condition and continues to treat with the nxstage system one.Although requested, no additional information was 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: 8491787
• MDR Text Key: 141208200
• Report Number: 3003464075-2019-00010
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,04/08/2019

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?: 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: 03/13/2019
• Initial Date FDA Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Weight: 29