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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-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Congestive Heart Failure (1783); Dyspnea (1816); Loss of consciousness (2418); Low Oxygen Saturation (2477)
Event Date 08/21/2020
Event Type  Injury  
Manufacturer Narrative
There was no indication of a device malfunction. 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 provides information on the risks associated with dialysis therapy and suggested actions, instructions, cautions and warnings to enable patients to treat safely and effectively. The physician confirmed that the patient was non-compliant with the prescribed treatment frequency leading up to the reported event. (b)(4).
 
Event Description
A report was received on 04 sep 2020 from a health professional, stating that a (b)(6) male patient with a medical history including chronic glomerulonephritis, hypertension and end stage renal disease, experienced dyspnoea and loss of consciousness and was admitted to the intensive care unit after a home hemodialysis therapy on (b)(6) 2020. Additional information was received on 17 sep 2020 from the nephrologist who stated that when medical services arrived to the patient, he was hypoxemic and experiencing pulseless electrical activity (pea), diagnosed with cardiac arrest. Resuscitative measures were initiated, return of spontaneous circulation (rosc) occurred after eight minutes and the patient was transferred to the intensive care unit (icu) with a diagnosis of cardiac arrest and congestive heart failure (chf). Per the nephrologist, in the time leading up to the event, the patient was not compliant with treatment frequency. Per the nephrologist, the event and icu admission were due to lack of compliance with prescribed treatment frequency.
 
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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 Key10607449
MDR Text Key209208410
Report Number3003464075-2020-00064
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeFI
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3-A
Device Catalogue NumberCHRONIC HI-FLOW CYCLER, ROHS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
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