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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-505
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/14/2020
Event Type  malfunction  
Manufacturer Narrative
The device was discarded by the user and not retained 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.
 
Event Description
A report was received on 14 feb 2020 from the nurse of a (b)(6) year old female patient in critical care for unspecified pathology, stating the cartridge arterial luer broke within the patient¿s central venous catheter (cvc) during a continuous renal replacement therapy (crrt) treatment on (b)(6) 2020. Additional information was received on 20 feb 2020 from the facility's charge nurse (cn) stating a physician was able to remove the broken piece of luer from the patient's cvc. No repair or replacement was required and no symptoms were experienced. The patient continues to treat with the nxstage system using their catheter for vascular access.
 
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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
9784505276
MDR Report Key9781789
MDR Text Key188245809
Report Number3003464075-2020-00015
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
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Model NumberCAR-505
Device Catalogue NumberCAR-505
Device Lot Number90678015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/03/2020 Patient Sequence Number: 1
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