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 Hemorrhage/Bleeding (1888); Convulsion/Seizure (4406)

Event Date 03/18/2022

Event Type  Injury  

Event Description

A report was received on (b)(6) 2022 from the caregiver of a (b)(6) male with a medical history including diabetes and end stage renal disease, who stated the patient experienced seizure like activity during a home hemodialysis treatment on (b)(6) 2022.The patient's access needles became dislodged and they lost an unspecified amount of blood.Per the caregiver, emergency medical services were called, and the patient was transported to hospital.Additional information was received on (b)(6) 2022 from the home therapy nurse (htn) who did not have an estimate for blood loss.The patient received a blood transfusion (nos) in hospital, recovered without sequelae and resumed treatment with nxstage device following release.

Manufacturer Narrative

The involved cycler 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 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.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
• MDR Report Key: 14051486
• MDR Text Key: 288861545
• Report Number: 3003464075-2022-00009
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2018
• 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 Sex: Male
• Patient Weight: 113 KG