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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Swelling (2091)
Event Date 12/30/2019
Event Type  Injury  
Manufacturer Narrative
The device was not received for evaluation. A review of the device history record confirmed the product was released meeting all quality criteria and manufacturing specifications. Udi: (b)(4).
 
Event Description
A report was received on 14 jan 2020 from the home therapy nurse (htn) regarding a (b)(6) female patient with a prior medical history significant for congestive heart failure, hypertension, anemia, right lung lower lobe malignancy and resection of same, rejection of renal transplant and postpartum cardiomyopathy, who removed insufficient fluid during home hemodialysis treatments and presented to the hospital on (b)(6) 2019. Additional information was received on 15 jan 2020 from the htn which revealed the patient experienced shortness of breath, cough and leg swelling on admission to hospital. Treatment in hospital included dialysis treatments and changes to antihypertensives and diuretics. Symptoms improved and the patient was released from hospital on (b)(6) 2020 in stable condition to continue dialysis therapy with the nxstage system one.
 
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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 Key9646511
MDR Text Key177642939
Report Number3003464075-2020-00005
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 01/01/2005,01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
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, ROHS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/30/2020 Patient Sequence Number: 1
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