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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 Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2019
Event Type  malfunction  
Event Description
Nurse was starting a continuous veno-venous hemofiltration on patient and opened the package and tubing had 2 male adapters vs male/female adapter. A new package needed to be opened.
 
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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 Key8695275
MDR Text Key147873989
Report Number8695275
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 06/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAR-500
Device Catalogue NumberNX25-0520
Device Lot Number90178009
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2019
Event Location Hospital
Date Report to Manufacturer06/13/2019
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? No
Type of Device Usage

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