MAUDE Adverse Event Report: NXSTAGE SYSTEM ONE; HEMODIALYSIS SYSTEM

Model Number CYCD2E

Device Problems Particulates (1451); Filtration Problem (2941); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

The patient's daughter who performs the hemodialysis at home noted a whitish particulate matter floating in the rinse back venous tubing.There is a suspected filtration issue and a foreign material present in the device.The daughter was asked to collect a sample for analysis.The patient remained in his usual state of health throughout and after the home hemodialysis treatment.

• Brand Name: SYSTEM ONE
• Type of Device: HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE; lawrence MA 01843
• MDR Report Key: 4729773
• MDR Text Key: 5666529
• Report Number: MW5042270
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CYCD2E
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Weight: 59