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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 Unexpected Therapeutic Results (1631)
Patient Problems Edema (1820); Weight Changes (2607)
Event Date 03/12/2019
Event Type  Injury  
Manufacturer Narrative
The cycler has not been received for evaluation. A device history record (dhr) review was conducted for the cycler which revealed the device met all manufacturing requirements and specifications prior to release of the unit. Factors outside the scope of nxstage can contribute to fluid overload. Udi: (b)(4). Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on 13 mar 2019 from a (b)(6) female with unknown comorbidities who stated she was hospitalized with weight gain and edema following hemodialysis therapy where the programmed amount of fluid was not removed on (b)(6) 2019. Additional information received on (b)(6) 2019 revealed that the patient was hospitalized (dates not provided) and received unspecified treatment to remove excess fluid. She was subsequently discharged in stable condition and continues to treat with the nxstage system one. Although requested, no additional information was received.
 
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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 Key8491787
MDR Text Key141208200
Report Number3003464075-2019-00010
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
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 Received03/13/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/08/2019 Patient Sequence Number: 1
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