MAUDE Adverse Event Report: NXSTAGE KIDNEY CARE, INC. PUREFLOW¿ B SOLUTION; DIALYSATE CONCENTRATE FOR HEMODIALYSIS

Catalog Number RFP-404

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2016

Event Type  malfunction  

Event Description

Bag nxstage pureflow b solution 5000 ml had cracked next to one of the tubing attachment points at it's joint with the bag causing the bag to leak and loose a majority of it's fluid.This occurred prior to the bag being used for the patient's dialysis.Icu nurses report that this has occurred dozens of times in a similar manner and they have not reported the failure prior.

• Brand Name: PUREFLOW¿ B SOLUTION
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS
• Manufacturer (Section D): NXSTAGE KIDNEY CARE, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 5948758
• MDR Text Key: 54644832
• Report Number: 5948758
• Device Sequence Number: 1
• Product Code: KPO
• 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: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: RFP-404
• Device Lot Number: F1606177
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DIALYSIS