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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 Low Blood Pressure/ Hypotension (1914); Palpitations (2467)
Event Date 02/20/2018
Event Type  Injury  
Manufacturer Narrative
The cartridge was not returned for evaluation and a lot number was not provided. Without a lot number, a review of the device history record (dhr) could not be performed. Biocompatibility has been established. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage system one user guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and the instructions for use include warnings to observe the patient and monitor physical status for potential complications. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on 16 aug 2018 from the distributor, regarding a (b)(6) male patient who experienced symptoms of persistent cough, chest palpitations, and hypotension during therapy with nxstage products on (b)(6) 2018. No medical intervention was required and the patient continues to treat using a different nxstage cartridge and a dialyzer from another 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
9784505276
MDR Report Key7836975
MDR Text Key118894465
Report Number3003464075-2018-00032
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeSA
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,Followup
Report Date 01/01/2005,10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
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 Received10/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/31/2018 Patient Sequence Number: 1
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