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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-170-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Test Result (2695)
Event Date 01/08/2018
Event Type  Injury  
Manufacturer Narrative
The device was not retained for investigation. A device history record (dhr) review for the cartridge was conducted and revealed the product was released having met all design and acceptance requirements prior to release. All available information supports that the product was functioning as designed and there was no malfunction. Biocompatibility of the device has been established. The nxstage user guide includes platelet decrease as a potential risk associated with dialysis treatments. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on 9 jan 2018 indicating that on (b)(6) 2018 a (b)(6) male hemodialysis patient had a decrease in platelets. He experienced an increase in bleeding time and bleeding from his fistula toward the end of treatment. No medical intervention was required. The patient continues to treat using the nxstage system one and a dialyzer from a different manufacturer.
 
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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 Key7211729
MDR Text Key97954755
Report Number3003464075-2018-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2018
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number70177011
Other Device ID Number+M535CAR172C0/$$0918701770116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2017
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: 01/23/2018 Patient Sequence Number: 1
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