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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 NX1000-16-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Dyspnea (1816); Headache (1880); High Blood Pressure/ Hypertension (1908); Nausea (1970); Vomiting (2144); Chills (2191)
Event Date 02/16/2021
Event Type  Injury  
Manufacturer Narrative
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. Based on the available information, there is no evidence to indicate that a malfunction occurred. The event is considered likely related to contamination of the central venous catheter due to a use error involving incorrect patient connections. The nxstage system one user guide states that a trained and qualified person must observe all treatments. It provides instructions and warnings regarding correct connections, the use of aseptic technique and the prevention of infection. Udi: (b)(4).
 
Event Description
A report was received on 16 feb 2021 from the (b)(6) of a (b)(6) year old male patient with a medical history including hypertension, type ii diabetes and end stage renal disease, who stated the patient experienced hypertension (nos) and attended the emergency room (er) after performing a home hemodialysis treatment on (b)(6) 2021. Additional information was received on 22 feb 2021 from the (b)(6) who stated the patient presented to the er with a blood pressure of 166/83, shortness of breath, headache, nausea, vomiting, abdominal pain and chills. He was admitted on (b)(6) 2021 for observation, labs and prophylactic administration of intravenous antibiotics (cefepime 1 g and vancomycin, dose not specified). The patient was discharged in stable condition on (b)(6) 2021 and has resumed therapy with the nxstage system.
 
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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
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key11455261
MDR Text Key239079301
Report Number3003464075-2021-00009
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170469
Exemption Number5645646
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-16-A
Device Catalogue NumberCYCLER VERSIHD 1.0, NO NIBP
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 Received02/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/10/2021 Patient Sequence Number: 1
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