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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number CAR-500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Shock (2072); Peritonitis (2252)
Event Date 06/14/2021
Event Type  Injury  
Manufacturer Narrative
The cartridge was discarded and was not available for evaluation. A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly.
 
Event Description
A report was received on 30 jun 2021 from the risk manager (rm) of a (b)(6) male critical care patient admitted to the intensive care unit (icu) for acute on chronic kidney failure, spontaneous bacterial peritonitis and shock, stating that continuous renal replacement therapy (crrt) was terminated without rinseback after troubleshooting system alarms, and the patient experienced an estimated blood loss of 310ml on (b)(6) 2021. The patient received a blood transfusion (nos) secondary to a low hematocrit (value not provided) level later in the day on (b)(6) 2021. Additional information was received on 30 jun 2021 from the rm stating that the patient recovered to baseline status of admission to the icu and was able to resume crrt with new cartridge on (b)(6) 2021.
 
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Brand NameNXSTAGE SYSTEM ONE
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
Manufacturer (Section G)
MEDIMEXICO S. DE R. L. DE C. V
av. valle imperial no. 10523
parque industrial valle sur
tijuana 22180
MX 22180
Manufacturer Contact
paula rogalski
nxstage medical, inc.
350 merrimack street
lawrence, MA 01843
MDR Report Key12100740
MDR Text Key259589676
Report Number3003464075-2021-00032
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2022
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Device Lot Number01078004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/01/2021 Patient Sequence Number: 1
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