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

Model Number CAR-172-C

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

Patient Problem Test Result (2695)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

There is no information to indicate that a malfunction occurred. The product meets all quality criteria and manufacturing specifications prior to release. Adverse reactions are known risks of hemodialysis, and the nxstage user guide and instructions for use include platelet decrease as a potential risk associated with dialysis therapy. The documents include warnings to monitor for potential adverse reactions. Biocompatability has been established.

Event Description

A report was received on 25 nov 2020 from a healthcare professional regarding a (b)(6) year old male patient with end stage renal disease, who experienced a platelet decrease while performing hemodialysis treatments with the nxstage system. Additional information was received on 04 dec 2020 from a healthcare professional, stating the patient began hemodialysis therapy with the nxstage system on (b)(6) 2020 and experienced an increased bleeding tendency and prolonged clotting time. No medical intervention has been required.

• 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: 11015316
• MDR Text Key: 221746421
• Report Number: 3003464075-2020-00080
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: SW
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/15/2020 Patient Sequence Number: 1