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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Cyanosis (1798); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Respiratory Failure (2484); Blood Loss (2597)
Event Date 07/28/2020
Event Type  Injury  
Manufacturer Narrative
The cartridge was discarded and was not available for evaluation. A review of the device history record (dhr) was conducted for the reported lot number and confirmed the product was released for distribution having met quality and manufacturing specifications and requirements. The nxstage system one user guide and car-172-c instructions for use (ifu) provide information and warnings for use of the device. The documentation warns the cartridge has multiple connection points, stating that failure to make the proper connections can cause compromised treatment and outlines measures to take to reduce the risk of accidental disconnections. A trained and qualified person must observe all treatments, check the system for blood and fluid leaks during treatment, and pay close attention to the blood lines and access connections ensuring all manual connections are secure and fluid tight.
 
Event Description
A report was received on 01 aug 2020 from a healthcare professional regarding a (b)(6) year old male patient with end stage renal disease, stating the venous line became ¿maladjusted¿ during a home hemodialysis treatment, resulting in blood loss, decreased blood pressure, loss of consciousness and hospital admission for a blood transfusion on (b)(6) 2020. Additional information was received on 11 aug 2020 from a healthcare professional who specified the ¿maladjustment¿ as disconnection of the venous line from the patient¿s central venous catheter. Symptoms also included cyanosis and respiratory arrest with blood loss estimated at 1. 5l. The patient was transfused with two units of blood, their condition stabilized, and they were discharged from hospital on (b)(6) 2020.
 
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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 Key10439197
MDR Text Key204697664
Report Number3003464075-2020-00056
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/01/2005,08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2021
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number90777005
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 Received08/01/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/21/2020 Patient Sequence Number: 1
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