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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 Material Puncture/Hole (1504); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 08/15/2020
Event Type  malfunction  
Event Description
Perfusionist replacing crrt machine filter when he noticed the new filter tubing had a hole and defect in the tubing. Inspection of the tubing occurred prior to set-up and was never attached to the patient/used.
 
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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 Key10430422
MDR Text Key203665578
Report Number10430422
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 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Device Lot Number91278006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2020
Event Location Hospital
Date Report to Manufacturer08/20/2020
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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