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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2017
Event Type  malfunction  
Manufacturer Narrative
The cartridge associated with the event has not been received for evaluation. A photo of the involved cartridge was visually reviewed which showed the broken luer. A review of the device history record (dhr) of the reported lot number confirmed no related defects were found during the manufacturing and the lot was released for distribution having met all product design requirements. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on (b)(6) 2017 from a critical care facility regarding a broken luer on the venous line of the cartridge. There was no report of adverse impact to the patient.
 
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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
9786874700
MDR Report Key7048558
MDR Text Key93303616
Report Number3003464075-2017-00051
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2018
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Device Lot Number61178012
Other Device ID Number+M535CAR5000/$$081861178012X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2016
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: 11/21/2017 Patient Sequence Number: 1
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