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

Model Number NX1000-16-A

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

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Headache (1880); High Blood Pressure/ Hypertension (1908); Nausea (1970); Vomiting (2144); Chills (2191)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.Based on the available information, there is no evidence to indicate that a malfunction occurred.The event is considered likely related to contamination of the central venous catheter due to a use error involving incorrect patient connections.The nxstage system one user guide states that a trained and qualified person must observe all treatments.It provides instructions and warnings regarding correct connections, the use of aseptic technique and the prevention of infection.Udi: (b)(4).

Event Description

A report was received on 16 feb 2021 from the (b)(6) of a (b)(6) year old male patient with a medical history including hypertension, type ii diabetes and end stage renal disease, who stated the patient experienced hypertension (nos) and attended the emergency room (er) after performing a home hemodialysis treatment on (b)(6) 2021.Additional information was received on 22 feb 2021 from the (b)(6) who stated the patient presented to the er with a blood pressure of 166/83, shortness of breath, headache, nausea, vomiting, abdominal pain and chills.He was admitted on (b)(6) 2021 for observation, labs and prophylactic administration of intravenous antibiotics (cefepime 1 g and vancomycin, dose not specified).The patient was discharged in stable condition on (b)(6) 2021 and has resumed therapy with the nxstage system.

• 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: nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 11455261
• MDR Text Key: 239079301
• Report Number: 3003464075-2021-00009
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170469
• Exemption Number: 5645646
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-16-A
• Device Catalogue Number: CYCLER VERSIHD 1.0, NO NIBP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 130