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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 Material Rupture (1546)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/05/2021
Event Type  Injury  
Manufacturer Narrative
The cartridge was discarded and was not available for evaluation. All product is released having met all manufacturing specifications and quality requirements. 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 (b)(6) 2021 from the coronary care unit (ccu) nurse manager (nm) of an (b)(6)-year-old female patient with heart failure and acute kidney injury, stating that the filter ruptured resulting in an estimated blood loss of 250ml during a continuous renal replacement therapy (crrt) on (b)(6) 2021. Additional information was received on 06 may 2021 from the ccu nm stating that the patient had a hemoglobin decrease of approximately 1 gram (exact number not provided) and received one unit of blood. Following the event, the patient has recovered to the baseline status of admission to the ccu.
 
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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
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key11815548
MDR Text Key254046262
Report Number3003464075-2021-00023
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/12/2021 Patient Sequence Number: 1
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