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

Model Number NX1000-16-A

Device Problem Air/Gas in Device (4062)

Patient Problems Chest Pain (1776); Dyspnea (1816); Pleural Effusion (2010)

Event Date 12/07/2022

Event Type  Injury  

Event Description

A report was received on 07 dec 2022 from the home therapy nurse (htn) of a 61 year old male patient with a complex medical history including end stage renal disease, who stated the patient experienced altered sensation and chest pain with air noted in the bloodlines during an in-center hemodialysis treatment on (b)(6) 2022.Additional information was received on 08 dec 2022 and 13 dec 2022 from the htn who stated the patient also experienced shortness of breath (sob).The patient was started on oxygen via nasal cannula, placed in trendelenburg position, and sent to the emergency room (er) for evaluation.The patient was admitted (b)(6) 2022 for dyspnea and acute pleural effusion and discharged (b)(6) 2022.Following the event the patient has recovered without sequelae and resumed treatment with the nxstage system.

Manufacturer Narrative

The device was not received for evaluation.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 ; 9784505276
• MDR Report Key: 15995696
• MDR Text Key: 305614930
• Report Number: 3003464075-2022-00089
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170469
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NX1000-16-A
• Device Catalogue Number: CYCLER VERSIHD 1.0, NO NIBP MO
• 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: 05/27/2020
• 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: 61 YR
• Patient Sex: Male