MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. SYSTEM ONE S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number SYSTEM ONE S

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591)

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

Event Date 11/18/2019

Event Type  malfunction  

Event Description

Unit gives red alarm 502 when cycler is power on.Unable to run prime and rinse test.Manufacturer response for cvvh machine, system one s (per site reporter) mfg repaired device.There was a software issue.

• Brand Name: SYSTEM ONE S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 9659223
• MDR Text Key: 177376474
• Report Number: 9659223
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYSTEM ONE S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1