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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-500
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
Event Type  malfunction  
Event Description
Red access line of crrt cartridge was attached to blue port of pt's mahurkar. Line stuck and nurse unable to wiggle it to remove it from pt's mahurkar. Kelly clamp used to remove line with resulting line breaking off in the patient's mahurkar requiring the line to be rewired. Pt was leaving for operating room to get a liver transplant.
 
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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 st
lawrence MA 01843
MDR Report Key8554585
MDR Text Key143243917
Report Number8554585
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 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAR-500
Device Lot Number80978008
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 FDA03/08/2019
Event Location Hospital
Date Report to Manufacturer04/26/2019
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?
Type of Device Usage

Patient Treatment Data
Date Received: 04/26/2019 Patient Sequence Number: 1
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