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

Model Number NX1000-1

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

Patient Problems Dyspnea (1816); Weakness (2145); Chest Tightness/Pressure (2463); Hypervolemia (2664)

Event Date 12/25/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history record confirmed the product was released meeting all quality criteria and manufacturing specifications.Udi: (b)(4).

Event Description

A report was received on 26 dec 2019 from a (b)(6) year old female with end stage renal disease and hypertension, who stated she was symptomatic following insufficient fluid removal during three consecutive home hemodialysis treatments in (b)(6) 2019 and was admitted to hospital as a result.Symptoms were reported as chest tightness, shortness of breath and weakness.Additional information was received on 08 jan 2020 from the home therapy nurse (htn) which revealed the patient was hospitalized (b)(6) 2019 and discharged on (b)(6) 2019.No treatment details or discharge summary was provided, and the patient has resumed hemodialysis treatments with 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: 9610337
• MDR Text Key: 188241795
• Report Number: 3003464075-2020-00003
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050525
• 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: 01/01/2005,01/21/2020

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: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• 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: 12/26/2019
• Initial Date FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 85