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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908)
Event Date 09/02/2020
Event Type  Injury  
Manufacturer Narrative
The device was received for evaluation and passed testing that ensures functionality of the device and sensors.A review of the device history record 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 02 sep 2020 from the home therapy nurse (htn) of a (b)(6) male with a medical history of hypertension, chronic hypoxemic respiratory failure, obesity, type ii diabetes chronic anemia and end stage renal disease, who stated insufficient fluid was removed and the patient experienced shortness of breath during hemodialysis treatment on (b)(6) 2020.The patient was admitted to hospital for fluid overload on (b)(6) 2020.Additional information was received 14-15 sep 2020 from the htn who stated the patient had experienced shortness of breath and insufficient fluid removal for several days prior to the event.The patient was admitted 2 sep 2020 with acute on chronic hypoxemic respiratory failure, secondary to pulmonary edema and fluid overload and uncontrolled hypertension.The course of hospitalization included investigation of elevated troponin and procalcitonin, antibiotics for suspected pneumonia, adjustment of blood pressure medication, noninvasive bipap ventilation and dialysis to control volume status.They received instruction regarding home hemodialysis treatments and weight management.Symptoms resolved, the patient improved and was discharged on (b)(6) 2020 to continue home hemodialysis treatments utilizing the nxstage system.
 
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Brand Name
NXSTAGE SYSTEM ONE
Type of Device
HIGH 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 Key10606896
MDR Text Key209209150
Report Number3003464075-2020-00065
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 Nurse
Type of Report Initial
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberNX1000-3
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age39 YR
Patient Weight140
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