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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); High Blood Pressure/ Hypertension (1908); Hypervolemia (2664); Swelling/ Edema (4577)
Event Date 05/16/2021
Event Type  Injury  
Manufacturer Narrative
The involved device was not received for evaluation. 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. Factors outside the scope of nxstage therapy can impact the patient's weight, these include but are not limited to the accuracy with which intake is recorded, the weighing techniques used, and the patient's comorbidities. A search of the complaint database revealed no other serious events associated with this device. Udi: (b)(4).
 
Event Description
A report was received on 17 may 2021 from a (b)(6)-year-old female patient with a medical history of multiple comorbidities including end stage renal disease, stating she experienced increased blood pressure (nos), swelling of ankles/feet and fluid overload (nos) when an insufficient amount of programmed fluid was removed during a hemodialysis treatment on (b)(6) 2021. Additional information was received on 19 may 2021 from the home therapy nurse (htn) stating that the patient was admitted to hospital for abdominal pain on (b)(6) 2021. There was no response to the request for additional details.
 
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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
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key11924312
MDR Text Key253962998
Report Number3003464075-2021-00026
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-16-A
Device Catalogue NumberCYCLER VERSIHD 1.0,NO NIBP MOD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2020
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: 06/02/2021 Patient Sequence Number: 1
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