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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 NX1000-5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Pulmonary Edema (2020); Weight Changes (2607); Pericardial Effusion (3271)
Event Type  Injury  
Manufacturer Narrative
Since manufacture and release of the device in 2016, it has been serviced and maintained at the customer site by their trained and qualified internal facility biomedical engineers. Site records for servicing, maintenance and calibration were not available. The device history record (dhr) was reviewed and confirmed the device met all quality criteria and manufacturing specifications prior to release. Following this event, the cycler was sent to and received by the nxstage service and manufacturing site for evaluation. Testing showed that the ultrafiltration pump required calibration, after which the device passed all testing. When in critical care, the patient¿s hemodynamic, fluid, and electrolyte balance must be monitored regularly, and their total fluid balance must account for weighing technique, scale accuracy, fluid consumption and output. Patients in critical care have multiple potential sources of fluid input as part of their care plan which impact their fluid balance status. The user guide states that all treatments must be administered under a physician¿s prescription. A trained and qualified person must observe all treatments to monitor vital signs in response to therapy, their general well-being and physical status, and to promptly respond to harmful conditions that may occur. Udi #: (b)(4).
 
Event Description
A report was received on 06 nov 2019 from a biomedical engineer regarding an adult patient in critical care for pulmonary edema, pericardial effusion, and generalized edema who experienced worsened generalized edema and weight increase during continuous veno-venous hemofiltration (cvvh) treatments using the nxstage system on an unspecified date. Additional information was received on 24 feb 2020 from the nurse stating the patient was not responding as expected and had worsened generalized edema after treating on the nxstage device for multiple unspecified days. Despite requests, no information regarding related medical intervention was provided. Fluid balance details during this time, outlining the patient¿s intake and output, including medically administered fluids, were not provided.
 
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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 Key9847883
MDR Text Key188244155
Report Number3003464075-2020-00016
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/01/2005,03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-5
Device Catalogue NumberACUTE CYCLER 3RD ED W/ ONEVIEW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
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 Received02/19/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/18/2020 Patient Sequence Number: 1
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