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

Model Number NX1000-1

Device Problem Improper Flow or Infusion (2954)

Patient Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Hypovolemia (2243)

Event Date 12/13/2022

Event Type  Injury  

Event Description

A report was received on 20 dec 2022 from the caregiver of a 67 year old male patient with a medical history including end stage renal disease, who stated an excessive amount of programmed fluid was removed during a home hemodialysis treatment on (b)(6) 2022.The patient experienced decreased blood pressure (58/40 mmhg) and had to go to hospital.Additional information was received on 22 dec 2022 from the health care processional (hcp) who stated the patient also experienced chest pain, breathlessness, and dizziness and was admitted (b)(6) 2022.The patient received unspecified fluids, and was discharged the following day, (b)(6) 2022, with instructions to increase their target dry weight.Following the event the patient has recovered without sequelae and resumed treatment with the nxstage system.

Manufacturer Narrative

The involved cycler was not received for evaluation.Factors outside the scope of nxstage therapy can impact the patient''s weight, these include but are not limited to the accuracy with which intake is recorded, the weighing techniques used, and the patient''s comorbidities.The nxstage system one user guide provides information on the risks associated with dialysis therapy and suggested actions, instructions, cautions and warnings to enable patients to treat safely and effectively.

• 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: 16111598
• MDR Text Key: 306785476
• Report Number: 3003464075-2023-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2013
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 86 KG