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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 NX1000-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypervolemia (2664); Test Result (2695)
Event Date 10/24/2019
Event Type  Injury  
Manufacturer Narrative
The involved cycler was not received for evaluation. The cycler serial number was not provided. Without a serial number, a review of the device history record (dhr) was unable to be performed.
 
Event Description
A report was received on (b)(6) 2019 from the home therapy nurse (htn) of a (b)(6) year old male with a medical history of type ii diabetes with other diabetic kidney complications (nos), iron anemia in chronic kidney disease (ckd), iron deficiency anemia, hypertensive ckd with stage 5 ckd, and secondary hyperparathyroidism of renal origin, stating the patient was admitted to hospital on (b)(6) 2019 with volume overload and elevated cardiac enzymes. Additional information was received on (b)(6) 2019 from the htn stating the patient remains hospitalized at this time. Per the htn, there is no indication of a device malfunction and the physician stated the patient required reassessment of their dry weight. Although requested, no further information has 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 Key9347323
MDR Text Key167181084
Report Number3003464075-2019-00060
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E
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 Received10/24/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/20/2019 Patient Sequence Number: 1
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