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

Catalog Number RFP-404

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/07/2016

Event Type  malfunction  

Event Description

Nxstage pureflow b 5000 ml solution bag was pre-mixed when the pack was removed from the package new.The bag is divided into two chambers and is intended to be mixed by the caregiver at the time of administration by flexing the bag to break the separation between the two chambers per manufacturer provided instructions.As the bag was pre-mixed for an undetermined amount of time, it was sequestered as non-conforming and another bag was opened and used for the patient's treatment.

• Brand Name: NXSTAGE PUREFLOW¿ B SOLUTION
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st.; lawrence MA 01843
• MDR Report Key: 5996306
• MDR Text Key: 56366377
• Report Number: 5996306
• 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: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• 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: 09/14/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DIALYSIS