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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-172-C
Device Problems Fluid Leak (1250); Device Slipped (1584)
Patient Problems Fainting (1847); Test Result (2695)
Event Date 11/30/2019
Event Type  Injury  
Manufacturer Narrative
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. There was no device malfunction. The nxstage system one user guide and car-172-c instructions for use provide information and warnings for use of the device. A trained and qualified person must observe all treatments, check the system for blood and fluid leaks during treatment and pay close attention to the bloodline and access connections. The documentation warns to make sure all manual connections are secure and fluid-tight before starting treatment, and to secure caps and close clamps after priming and after each use.
 
Event Description
A report was received on (b)(6) 2019 from the home therapy nurse (htn) regarding a (b)(6) year old male with diabetes and end-stage renal disease who lost approximately 300ml blood, felt faint and unwell while performing a home hemodialysis treatment without a caregiver present and was transported to hospital on (b)(6) 2019. Additional information was received on (b)(6) 2019 from the htn who stated blood leaked from a loose cap on the heparin line of the blood tubing. The patient was admitted to hospital with decreased hemoglobin (77g/l), and received erythropoietin and iron (doses unspecified). The patient remained hospitalized as of (b)(6) 2019 with a plan to provide additional training for the patient upon discharge.
 
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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 Key9450564
MDR Text Key174269819
Report Number3003464075-2019-00074
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2021
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number90777025
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 Received11/30/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/11/2019 Patient Sequence Number: 1
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