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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 Fluid/Blood Leak (1250)
Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Shock (2072); Loss of consciousness (2418)
Event Date 04/22/2021
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed the device met all quality criteria and manufacturing specifications prior to release. The nxstage system one user guide provide information and warnings for use of the device. The user guide warns that treatment with the nxstage system one should only be done under the responsibility of a physician and performed by a trained and qualified person. A trained and qualified person must observe all treatments, check the system for blood leaks, pay close attention to the bloodlines and access during treatment and respond promptly and appropriately to all alarms and harmful conditions during treatment. (b)(4).
 
Event Description
A report was received on (b)(6) 2021 from a (b)(6) patient with a medical history of multiple comorbidities and end stage renal disease, stating the patient experienced bleeding near the access site approximately 8 minutes into a hemodialysis treatment on (b)(6) 2021 and emergency medical services (ems) were called. Additional information was received on 23 apr 2021 from the home therapy nurse (htn) stating that ems estimated a 2-liter blood loss at the scene. The patient was unresponsive and transported to the emergency department (ed), arriving in cardiac arrest due to hemorrhagic shock. In the ed, the patient was intubated and sedated. Resuscitation was performed successfully and included the facility¿s ¿massive transfusion protocol¿, achieving a return of spontaneous circulation (rosc). The patient stabilized, vascular surgery evaluated the patient¿s fistula and placed 2 sutures to achieve hemostasis.
 
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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 Key11757423
MDR Text Key248404141
Report Number3003464075-2021-00020
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170469
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
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 MOD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2021
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: 04/30/2021 Patient Sequence Number: 1
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