MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE PUREFLOW B SOLUTION; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	RFP-404
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Two hemodialysis bags popped during activation could not be used for dialysis.New bags were obtained from pharmacy.

• Brand Name: NXSTAGE PUREFLOW B SOLUTION
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st.; lawrence MA 01843
• MDR Report Key: 7391748
• Report Number: 7391748
• Device Sequence Number: 16434415
• Product Code: KPO
• UDI-Device Identifier: M535RFP4040
• UDI-Public: +M535RFP4040/$$0819F1708254S
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018
• Report Date (Section F): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/01/2019
• Device Model Number: RFP-404
• Device Lot Number: F1708254S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 03/22/2018