MAUDE Adverse Event Report: NX STAGE NX STAGE NOCTURNAL CARTRIDGE; NX STAGE CARTRIDGE

Model Number CAR-172

Device Problems Product Quality Problem (1506); Defective Component (2292)

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

Event Date 02/15/2017

Event Type  Injury  

Event Description

Pt brought in 3 cartridges to clinic for medical director and rn to view cassette with excess soft plastic on spikes.Nx stage clinic educator ce happened to be here in the clinic when patient brought in the cassette.The ce called in defective cassettes to nx stage to begin the evaluation.Replacement cassettes ordered for the pt within 24 hours.Pt's wife reported the next 3 boxes of nocturnal cassette spikes were the same.Pt and his wife reported they were worried the plastic may break loose into his bloodstream.Nx stage ce was in town and met patient in clinic and dr.(b)(6) saw patient as well.Dr.(b)(6) and staff gave pt alternatives until issue is resolved.Either daytime hd or in-center hd.Patient states he will discuss with his wife and let us know how they want to dialyze until the issue has resolved.

• Brand Name: NX STAGE NOCTURNAL CARTRIDGE
• Type of Device: NX STAGE CARTRIDGE
• Manufacturer (Section D): NX STAGE ; 350 merrimack st. ; lawrence MA 01843
• MDR Report Key: 6416695
• MDR Text Key: 70441912
• Report Number: MW5068524
• Device Sequence Number: 5
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2017
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAR-172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 145