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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 Device Alarm System (1012); Obstruction of Flow (2423)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 06/20/2019
Event Type  malfunction  
Event Description
Staff was using the nxstage renal replacement therapy (rrt) cartridge to perform kidney dialysis on a patient in the intensive care unit, and while the nurse was in room caring for patient, she observed a blood clot going through a line that was returning blood back to the patient.She stopped the machine, documented the blood clot in the line, and contacted her charge nurse.The pump that was running the rrt cartridge did alarm prior to the clot being found, but the alarm was warning of the patient's blood pressure being high, not warning of any sort of malfunction.
 
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Brand Name
NXSTAGE CARTRIDGE EXPRESS
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
MDR Report Key8767477
MDR Text Key150272520
Report Number8767477
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 06/24/2019,06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCAR-505
Device Catalogue NumberCAR-505
Device Lot Number90378018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2019
Event Location Hospital
Date Report to Manufacturer07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age7300 DA
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