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

Model Number NX1000-3

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/27/2023

Event Type  Death  

Event Description

A report was received on 27 dec 2023 from the home therapy nurse (htn) of a 44 year old male patient with a medical history including diabetes and end stage renal disease, who stated the patient experienced uncontrolled bleeding after removing their needles and expired following a home hemodialysis treatment on 27 nov 2023.Additional information was received on 27 dec 2023 from the htn who stated the patient was found alone, disconnected from the device, with the dialysis needles removed from his access site and an unspecified amount of blood loss noted.Emergency medical services (ems) was called however the patient expired prior to their arrival.Per the htn the patient''s death is unrelated to nxstage product or therapy.

Manufacturer Narrative

Investigation found there was no device malfunction.The cycler was received for evaluation and successfully passed testing.The available log files were reviewed and revealed no additional insights.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.The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns all treatments must be administered under a physician''s prescription and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.Udi: (b)(4).

• 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: 18574997
• MDR Text Key: 333636587
• Report Number: 3003464075-2024-00011
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122051
• 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: 01/24/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2008
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 75 KG