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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Test Result (2695)
Event Date 04/11/2019
Event Type  Injury  
Manufacturer Narrative
There was no indication of a device malfunction. A review of the device history record (dhr) was performed and revealed no related defects during the manufacturing process. The lot was released for distribution having met all product design requirements. The instructions for use warns that the device must be used under the prescription of a physician. The user guide states that a decrease in platelet count is a potential risk associated with dialysis therapy and monitoring of the patient should be performed regularly to ensure an appropriate response to therapy. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on 17 apr 2019 from the nurse regarding a (b)(6) female with a history of (b)(6), who experienced platelet decreases after using the nxstage system one to perform hemodialysis therapy on multiple, unspecified dates. Additional information was received on 23 apr 2019 from the nurse stating the patient did not experience any additional symptoms and no medical intervention was required. Follow up information was received on 20 may 2019 from the physician which revealed the patient experienced generalized bruising in association with their decreased platelets. The patient changed to a system from a different manufacturer (nos) and has recovered.
 
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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 Key8649306
MDR Text Key146355785
Report Number3003464075-2019-00016
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeEZ
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/01/2020
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number80977027
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 Received05/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/29/2019 Patient Sequence Number: 1
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