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 Problem Test Result (2695)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

There was no indication of a device malfunction.All devices must meet quality requirements and manufacturing specifications prior to release.Bio-compatibility has been established.The instructions for use warns that the device must be used under the prescription of a physician.The user guide includes a decrease in platelet count as a potential risk associated with dialysis therapy and states monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.

Event Description

A report was received on 22 feb 2020 from a healthcare professional regarding an adult with end stage renal disease who experienced a platelet decrease after using the nxstage device, dates not provided.The patient's kidney transplant surgery was delayed due to the reported issue on an unspecified date, approximately two months earlier, prior to the date the report was received.

• 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: 9861195
• MDR Text Key: 188244377
• Report Number: 3003464075-2020-00018
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: TC
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other