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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
Model Number CAR-505
Device Problems Leak/Splash (1354); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 04/07/2021
Event Type  malfunction  
Event Description
Continuous renal replacement therapy (crrt) rn presented a defective cartridge. As per crrt rn, he was priming the nxstage machine and noticed that cartridge was leaking. He sequestered the defective cartridge. Clinical coordinator reported to nxstage and nxstage will send a kit so we can send the cartridge back to them for further investigation. We have 3 separate incidents of leaking cartridges but no sofi was done, but same process was followed. Report for davita submitted. Machine serial number and cartridge lot numbers submitted to nxstage and included in davita report (rem) patients were safe and no reports of harm done. Manufacturer response for dialysis machine, nxstage (per site reporter). You would have to check with nxstage.
 
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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 Key12391016
MDR Text Key268922315
Report Number12391016
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 Risk Manager
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAR-505
Device Lot Number10278049
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2021
Event Location Hospital
Date Report to Manufacturer08/31/2021
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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