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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
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Diarrhea (1811); No Code Available (3191)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative
The involved cycler was not returned for evaluation and a serial number was not provided. All devices must meet quality requirements and manufacturing specifications prior to release. Factors outside the scope of nxstage therapy can impact the patient's weight, these include but are not limited to the accuracy with which intake is recorded, the weighing techniques used, and the patient's comorbidities.
 
Event Description
A report was received on 08 jul 2020 from a home therapy nurse (htn) regarding a (b)(6)year old female patient with end stage renal disease and unspecified congenital anomaly, stating an insufficient amount of fluid was removed during multiple home hemodialysis treatments (dates not specified) and the patient was hospitalized. Additional information was received on 10 jul 2020 from the htn stating the patient was admitted to hospital on (b)(6) 2020 with diarrhea, ¿stomach bug", and fluid retention. The patient received hemodialysis treatments while hospitalized and was discharged on (b)(6)2020. Although requested, other treatment details, the course of hospitalization, and the discharge diagnosis have not been 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 Key10369859
MDR Text Key207508192
Report Number3003464075-2020-00044
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-16
Device Catalogue NumberCYCLER VERSIHD, NO NIBP MODULE
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 Received07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/05/2020 Patient Sequence Number: 1
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