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

Model Number CAR-505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. In the critical care setting, the patient¿s treatments are prepared and continuously monitored by trained healthcare professionals. The instructions for use includes the following warnings: secure caps and close clamps after priming and after each use to prevent blood loss or air entering the patient blood lines. Before starting treatment, make sure all manual connections are secure and fluid-tight, but not over-tight. A trained and qualified observer must check the system for blood and fluid leaks during treatment and pay close attention to the blood line and access connections.

Event Description

A report was received on 18 nov 2019 from the nurse of a (b)(6) male being treated in the critical care unit for a gastrointestinal bleed and low hemoglobin (7. 3g/dl), who experienced hypotension and lost approximately 75ml blood via a loose cartridge connection during a hemodialysis treatment on (b)(6) 2019. Treatment was terminated without rinseback of the dialysis circuit, with blood loss totaling approximately 250ml. Additional information was received on 21 nov 2019 from the nurse stating the patient became unresponsive, required intubation and was transfused with 2 units of blood. Hb improved to 9. 2g/dl post transfusion, the patient recovered without sequelae and resumed therapy with the nxstage system.

• 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: 9385674
• MDR Text Key: 168810447
• Report Number: 3003464075-2019-00071
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/01/2005,11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/01/2021
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Device Lot Number: 90778012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/27/2019 Patient Sequence Number: 1