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

Model Number CAR-172

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

Patient Problems Low Blood Pressure/ Hypotension (1914); No Code Available (3191)

Event Date 04/19/2020

Event Type  Injury  

Manufacturer Narrative

A cartridge lot number was not provided. Without a lot number, a review of the device history record (dhr) is unable to be performed. All product is released having met all manufacturing specifications and quality requirements. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. Biocompatability has been established.

Event Description

A report was received on 28 jul 2020 from a healthcare professional regarding a (b)(6) year old male with significant comorbidities including dependence on mechanical ventilation, hemiplegia, previous cardiac arrest and end stage renal disease, stating the patient experienced hypotension and abdominal distress during a hemodialysis session on (b)(6) 2020. No medical intervention was reported, and the patient recovered without sequelae, continuing to perform hemodialysis treatments with the nxstage system one and a dialyzer from a different manufacturer.

• 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: 10430281
• MDR Text Key: 203654678
• Report Number: 3003464075-2020-00050
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: SA
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CAR-172
• Device Catalogue Number: CAR-172
• 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: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 08/20/2020 Patient Sequence Number: 1