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

Model Number NX1000-1

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Cardiac Arrest (1762)

Event Date 01/30/2023

Event Type  Death  

Manufacturer Narrative

The device was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.There was no indication of a device malfunction from the available information.The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.Udi: (b)(4).

Event Description

A report was received on 02 feb 2023 from the home therapy nurse (htn) of a 60 year old female patient with a medical history of multiple comorbidities and end stage renal disease who was approved for performing solo home hemodialysis therapy, stating the patient expired during a hemodialysis treatment on (b)(6) 2023.Additional information was received on 02 feb 2023 from the home therapy nurse (htn) who confirmed the patient was found expired the following day with her needle (nos) dislodged.Per the nephrologist, the cause of death was determined to be cardiac arrest.

• 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: 16434944
• MDR Text Key: 310136714
• Report Number: 3003464075-2023-00021
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2009
• 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): Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 51 KG