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

Model Number CAR-172-C

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Cyanosis (1798); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Respiratory Failure (2484); Blood Loss (2597)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

The cartridge was discarded and was not available for evaluation.A review of the device history record (dhr) was conducted for the reported lot number and confirmed the product was released for distribution having met quality and manufacturing specifications and requirements.The nxstage system one user guide and car-172-c instructions for use (ifu) provide information and warnings for use of the device.The documentation warns the cartridge has multiple connection points, stating that failure to make the proper connections can cause compromised treatment and outlines measures to take to reduce the risk of accidental disconnections.A trained and qualified person must observe all treatments, check the system for blood and fluid leaks during treatment, and pay close attention to the blood lines and access connections ensuring all manual connections are secure and fluid tight.

Event Description

A report was received on 01 aug 2020 from a healthcare professional regarding a (b)(6) year old male patient with end stage renal disease, stating the venous line became ¿maladjusted¿ during a home hemodialysis treatment, resulting in blood loss, decreased blood pressure, loss of consciousness and hospital admission for a blood transfusion on (b)(6) 2020.Additional information was received on 11 aug 2020 from a healthcare professional who specified the ¿maladjustment¿ as disconnection of the venous line from the patient¿s central venous catheter.Symptoms also included cyanosis and respiratory arrest with blood loss estimated at 1.5l.The patient was transfused with two units of blood, their condition stabilized, and they were discharged from hospital on (b)(6) 2020.

• 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: 10439197
• MDR Text Key: 204697664
• Report Number: 3003464075-2020-00056
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0321907770055
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/01/2005,08/21/2020

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 Expiration Date: 03/01/2021
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 90777005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/01/2020
• Initial Date FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 78