MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC.; DIALYZER, HIGH PERMEABILITY, SYSTEM

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 10/12/2017

Event Type  malfunction  

Event Description

Patient was receiving crrt treatment with no difficulties or issues.Five hours into treatment, crrt machine alarmed a green alarm with "looking for cycler" and error 901 in the right hand corner of the cycler.All pumps turned off at that time.The rn followed directions to restart cycler, and continued treatment for 5 minutes, then the machine alarmed again "looking for cycler".Blood manually returned, and nxstage called.The rn was guided through restart with nxstage, and cycler restarted and treatment resumed.An hour later, crrt machine alarmed "looking for cycler", blood manually returned, and crrt machine pulled out of operation.Per nxstage technician "not sure what would cause error 901".

• Type of Device: DIALYZER, HIGH PERMEABILITY, SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 6993414
• MDR Text Key: 90785926
• Report Number: 6993414
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1