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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number CAR-505
Device Problem Inadequate Instructions for Healthcare Professional (1319)
Patient Problem Insufficient Information (4580)
Event Date 04/25/2021
Event Type  malfunction  
Event Description
Crrt dialysis cassette discovered to be set-up in cvvh configuration vs cvvhd configuration. Physician orders for cvvhd and nxstage machine programed for cvvhd. Poor test/instrument design leading to inadequate or unclear instructions for use. No reminders for verification of what connections are made for patients in cvvhd vs cvvh. Request review of cartridge set-up. Please consider providing more definitive guidelines to cvvh vs cvvhd set-up when utilizing simple instructions via system one and provide a follow-up verification at the end of the cartridge set-up. The simple process minimally addresses therapy fluid bag set-up and monitoring. Recommend that this screen shot be updated to mention verifying cvvhd vs cvvh treatment connections as part of the verification follow-up before launching the treatment. The simple process minimally addresses therapy fluid bag set up and monitoring.
 
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Brand NameNXSTAGE CARTRIDGE EXPRESS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
MDR Report Key11974419
MDR Text Key255369657
Report Number11974419
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCAR-505
Device Lot Number00878015
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/19/2021
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer06/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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