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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-A
Device Problem Protective Measures Problem (3015)
Patient Problems Chest Pain (1776); Nausea (1970); Vomiting (2144); Cough (4457)
Event Date 12/08/2021
Event Type  Injury  
Event Description
A report was received on 09 dec 2021 from the home therapy nurse (htn) of a (b)(6) male patient with a medical history including multiple comorbidities and end stage renal disease, stating the patient was troubleshooting multiple alarms, experienced chest pain, cough and vomiting and was admitted to hospital following a hemodialysis treatment on (b)(6) 2021. Per the htn, treatment was terminated without rinseback. Additional information was received on 14 dec 2021 from the htn stating that patient was admitted to hospital from (b)(6) 2021 with an admitting diagnosis of nausea and vomiting. Per the htn, the patient has recovered without sequelae and continues to treat with the nxstage system.
 
Manufacturer Narrative
The device was received for evaluation and successfully passed testing. All devices must meet all quality criteria and manufacturing specifications prior to release. Available log files were retrieved and analyzed which showed device performance was without deficiency and was unremarkable. The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly. There was no indication of a device malfunction from the available information. Udi (b)(4).
 
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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 Key13113708
MDR Text Key282955441
Report Number3003464075-2021-00075
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-16-A
Device Catalogue NumberCYCLERVERSIHD1, NO NIBP MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2019
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: 12/29/2021 Patient Sequence Number: 1
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