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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 Bruise/Contusion (1754); Test Result (2695)
Event Date 11/12/2019
Event Type  Injury  
Manufacturer Narrative
There was no indication of a device malfunction. All product is released meeting all product design specifications and quality criteria. A device history review of the complaint database revealed no other events of this nature for the reported lot number. The instructions for use warns that the device must be used under the prescription of a physician. The user guide includes a decrease in platelet count as a potential risk associated with dialysis therapy and states monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.
 
Event Description
A report was received on 03 dec 2019 from the home therapy nurse (htn) of a (b)(6) male with a medical history of end-stage renal disease, diabetes, and a recent history of admission to hospital for treatment of leg wounds unrelated to nxstage, stating the patient experienced a decrease in platelet count while using the nxstage system on (b)(6) 2019. Additional information was received on 05 dec 2019 from the htn stating the patient experienced bruising. There was no report of medical intervention and although requested, additional information has not been provided.
 
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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 Key9504685
MDR Text Key173981861
Report Number3003464075-2019-00082
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2020
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number90777010
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 Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/20/2019 Patient Sequence Number: 1
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