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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 Gas Leak (2946)
Patient Problems Discomfort (2330); Cough (4457)
Event Date 10/11/2021
Event Type  Injury  
Manufacturer Narrative
There was no device malfunction. The device was received for evaluation and successfully passed testing, confirming proper functionality of the device and sensors, including the air detection sensors. Available log files were retrieved and analyzed which showed the cycler performed as designed and intended, alarming appropriately when alarm conditions were present. Per the log file review air alarms were present for 39 minutes prior to the patient event without evidence of air removal or troubleshooting. A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. All information supports the device was functioning as designed and intended with no malfunction. The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns that treatment should only be performed by a trained and qualified person who must respond promptly to harmful conditions during treatment. Udi: (b)(4).
 
Event Description
A report was received on 11 oct 2021 from the nurse of a (b)(6) year old female with a medical history including type ii diabetes, polycystic kidney disease (anephric), hypertension, hypothyroidism and end stage renal disease, who stated the patient experienced coughing and noted air in the venous line approximately two hours into a hemodialysis treatment on (b)(6) 2021. Additional information was received on 12-15 oct 2021 from the nurse who stated the patient also experienced chest discomfort. The patient was placed on her left side, all lines were clamped and emergency medical services (ems) were called. Upon ems arrival, the patient was given 2l of oxygen, transported to hospital and admitted for observation. The patient was discharged on (b)(6) 2021 to resume therapy with the nxstage system one.
 
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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
MDR Report Key12743725
MDR Text Key280053916
Report Number3003464075-2021-00063
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 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2016
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: 11/03/2021 Patient Sequence Number: 1
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