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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 08/20/2019
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed the device was released meeting all quality requirements and manufacturing specifications. 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 06 sep 2019 from a healthcare professional (hcp) via the distributor, stating a (b)(6) male had experienced a decrease in platelet count with no report of symptoms after treating with the nxstage system on (b)(6) 2019. Follow up information was received on 19 sep 2019 from the hcp stating the patient experienced bruising on (b)(6) 2019. The patient changed to a dialyzer from a different manufacturer and platelet count increased. No medical intervention was required.
 
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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 Key9124158
MDR Text Key165956445
Report Number3003464075-2019-00050
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeSW
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2020
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number90177028
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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 Received09/06/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/26/2019 Patient Sequence Number: 1
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