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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 NX1000-3
Device Problem Disconnection (1171)
Patient Problems Death (1802); Exsanguination (1841)
Event Date 08/01/2020
Event Type  Death  
Manufacturer Narrative
The involved cycler has not been received for evaluation. A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release. The reported event is attributed to a patient use error with their central venous catheter (cvc). The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly. Udi #: (b)(4).
 
Event Description
A report was received on (b)(6) 2020 from a home therapy nurse (htn), stating a (b)(6) year old female with a medical history of hypertension and end stage renal disease, was found cold and unresponsive with unclamped central venous catheter (cvc) lines, disconnected hemodialysis bloodlines, and a ¿puddle¿ of blood on the floor at an unspecified time while performing home hemodialysis treatment on (b)(6) 2020. Additional information was received (b)(6) 2020 from the htn stating the patient performed a home hemodialysis treatment without a care partner present and had disconnected their cvc from the nxstage system at the time of the event. Per the htn, the amount of blood loss was unknown, emergency services were called, and the patient was pronounced deceased on (b)(6) 2020. The htn stated that treatment details, amount of blood loss, and cause of death were unavailable.
 
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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 Key10467495
MDR Text Key204879791
Report Number3003464075-2020-00058
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
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 Received08/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2017
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: 08/28/2020 Patient Sequence Number: 1
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