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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-A
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Pneumonia (2011); Pulmonary Edema (2020); Respiratory Distress (2045)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) was performed and confirmed the product was released meeting all quality criteria and manufacturing specifications. 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. Udi #: (b)(4).
 
Event Description
A report was received on 23 nov 2020 from the home therapy nurse (htn) of a (b)(6) year old male patient with a medical history including end stage renal disease on dialysis, essential hypertension, focal segmental glomerulosclerosis, anemia in end stage renal disease, retained bullet, pneumonia and insomnia, stating the patient was admitted to hospital after an insufficient amount of fluid was removed during a home hemodialysis treatment on (b)(6) 2020. Additional information was received 25 nov - 10 dec 2020 from the htn stating insufficient fluid removal had been ongoing (no dates or details provided) and the patient was hospitalized with respiratory difficulty, pulmonary edema, and hemoptysis following hemodialysis therapy on (b)(6) 2020. The patient received hemodialysis treatments and unspecified antibiotics while hospitalized and blood cultures revealed no growth. The patient¿s diuretic medication (nos) was increased from 25mg/day to 50mg/day and the patient was discharged on (b)(6) 2020 with a diagnosis of atypical pneumonia.
 
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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 Key11015495
MDR Text Key221736353
Report Number3003464075-2020-00081
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3-A
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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