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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 NX1000-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Weakness (2145); Chest Tightness/Pressure (2463); Hypervolemia (2664)
Event Date 12/25/2019
Event Type  Injury  
Manufacturer Narrative
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 26 dec 2019 from a (b)(6) year old female with end stage renal disease and hypertension, who stated she was symptomatic following insufficient fluid removal during three consecutive home hemodialysis treatments in (b)(6) 2019 and was admitted to hospital as a result. Symptoms were reported as chest tightness, shortness of breath and weakness. Additional information was received on 08 jan 2020 from the home therapy nurse (htn) which revealed the patient was hospitalized (b)(6) 2019 and discharged on (b)(6) 2019. No treatment details or discharge summary was provided, and the patient has resumed hemodialysis treatments 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 Key9610337
MDR Text Key188241795
Report Number3003464075-2020-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E W/ SERVICE COMPUTER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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 Received12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/21/2020 Patient Sequence Number: 1
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