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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 Patient-Device Incompatibility (2682)
Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Urticaria (2278); Anxiety (2328)
Event Date 04/02/2019
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) for the involved cartridge lot was conducted which confirmed the product met all quality criteria and manufacturing specifications prior to release. Biocompatibility of the device has been established. There is no evidence to suggest that a product 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 also includes 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 03 apr 2019 from the home therapy nurse (htn) regarding a (b)(6) male with a history of a recent hypersensitivity type reaction during hemodialysis, who experienced anxiety, hypotension and hives at an unspecified time during a standard hemodialysis treatment on (b)(6) 2019. Treatment was terminated with rinseback and 25mg of intravenous (iv) benadryl was administered.
 
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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 Key8533116
MDR Text Key142543309
Report Number3003464075-2019-00012
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 01/01/2005,04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2020
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number90277027
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 Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/19/2019 Patient Sequence Number: 1
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