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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 Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Reaction to Medicinal Component of Device (4574)
Event Date 09/10/2021
Event Type  Injury  
Manufacturer Narrative
The patient experienced an adverse event with the same device model number on 3 additional dates. The event on (b)(6) 2021 is documented in mfr report # 3003464075-2021-00046. The event on (b)(6) 2021 is documented in mfr report # 3003464075-2021-00047. The event on (b)(6) 2021 is documented in mfr report # 3003464075-2021-00048. A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions. Biocompatibility of the device has been established.
 
Event Description
A report was received on 22 sep 2021 from the home therapy nurse (htn) of a (b)(6) year-old female patient with a medical history including multiple comorbidities and end stage renal disease, who stated the patient experienced ¿a dialyzer reaction¿ (nos) during a hemodialysis treatment on (b)(6) 2021. Additional information was received on 22 sep 2021 from the htn stating that the patient experienced shortness of breath (sob) with chest ''heaviness'' immediately after starting therapy and decreased blood pressure (nos) approximately 30 minutes prior to treatment termination on (b)(6) 2021. Per the htn, oxygen was applied.
 
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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
MDR Report Key12525085
MDR Text Key273086949
Report Number3003464075-2021-00045
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 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number10677008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2021
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: 09/24/2021 Patient Sequence Number: 1
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