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U.S. Department of Health and Human Services

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

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NX STAGE NX STAGE NOCTURNAL CARTRIDGE NX STAGE CARTRIDGE Back to Search Results
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.
 
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Brand NameNX STAGE NOCTURNAL CARTRIDGE
Type of DeviceNX STAGE CARTRIDGE
Manufacturer (Section D)
NX STAGE
350 merrimack st.
lawrence MA 01843
MDR Report Key6416695
MDR Text Key70441912
Report NumberMW5068524
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received03/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2018
Device Model NumberCAR-172
Device Lot Number61177019
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/16/2017 Patient Sequence Number: 1
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