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

Model Number NX1000-3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hypovolemia (2243); Loss of consciousness (2418); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/26/2021

Event Type  Injury  

Manufacturer Narrative

The device was received for evaluation and successfully passed testing with no malfunction identified.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.The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns that treatment should only be performed by a trained and qualified person who must respond promptly to harmful conditions during treatment, check the system for blood and fluid leaks during treatment and pay close attention to the bloodline and access connections.Udi: (b)(4).

Event Description

A report was received on 29 june 2021 from the caregiver (cg) of a (b)(6) year old male patient with a medical history of diabetes, coronary artery disease, and end stage renal disease, stating the patient was found unresponsive with blood on the floor (amount not specified) and a dislodged dialysis needle on (b)(6) 2021.Additional information was received on 30 june 2021 from the home therapy nurse (htn) who stated emergency services were called, the patient was taken to hospital and admitted overnight.Hemoglobin was 11.9g/dl on admission, falling to 9.7g/dl and 8.7g/dl while in hospital.The patient stabilized with unspecified intravenous fluids and ¿further treatment for hypovolemia due to acute blood loss¿, and was discharged from hospital the following day, (b)(6) 2021 to continue using the nxstage system one for hemodialysis therapy.

• 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
• MDR Report Key: 12195924
• MDR Text Key: 262510395
• Report Number: 3003464075-2021-00034
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• 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: 07/20/2021

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: 07/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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: 65 YR
• Patient Weight: 92