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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 CAR-172-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Pericardial Effusion (3271); Syncope/Fainting (4411)
Event Date 12/01/2021
Event Type  Injury  
Event Description
A report was received on 02 feb 2022 from the nurse of a (b)(6) male with extensive comorbidities including a recent hypersensitivity type reaction, anemia, arterio-venous malformations, cirrhosis with ascites, anxiety, hypertension, diabetes and end stage renal disease, who stated the patient experienced shortness of breath and a syncopal episode immediately upon beginning a hemodialysis treatment on (b)(6) 2021. Per the nurse, the patient was taken to the emergency department and admitted to hospital. Additional information was received on (b)(6) 2022 from the nurse who provided hospital records showing the patient also became hypertensive in the emergency department. Workup at the hospital included chest ct and transthoracic echocardiogram that diagnosed a pericardial effusion which was treated with creation of a pericardial window and removal of 300ml of fluid. Per the hospital record, the patient was discharged in stable condition on (b)(6) 2021 with a diagnosis of pericardial effusion.
 
Manufacturer Narrative
The patient experienced an adverse event with the same device model number on 2 additional dates. The event on (b)(6) 2021 is documented in mfr report # 3003464075-2022-00006. The event on (b)(6) 2022 is documented in mfr report # 3003464075-2022-00005. 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. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions. Biocompatibility of the device has been established.
 
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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 Key13516178
MDR Text Key287329704
Report Number3003464075-2022-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number10877005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2022 Patient Sequence Number: 1
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