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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 Insufficient Information (3190)
Patient Problems Congestive Heart Failure (1783); Dyspnea (1816); Edema (1820); Patient Problem/Medical Problem (2688)
Event Date 08/10/2018
Event Type  Injury  
Manufacturer Narrative
The device was not received for evaluation and no log files were available for analysis. A review of the device history record (dhr) for the cycler was conducted and revealed the product was released having met all design and manufacturing specifications and requirements. (b)(4).
 
Event Description
A report was received on 13 aug 2018 from the caregiver of a (b)(6) male with medical history significant for multiple cardiac and pulmonary comorbidities [chronic congestive heart failure (chf), coronary artery disease (cad), atrial fibrillation (af), chronic obstructive pulmonary disease (copd), hypertension and an aortic valve replacement (avr)], stating that the patient was hospitalized with fluid overload, peripheral edema and dyspnoea on (b)(6) 2018. Information received from the patient¿s home therapy nurse (htn) revealed that the patient was admitted on (b)(6) 2018 and discharged on (b)(6) 2018 with a diagnosis of acute on chronic systolic congestive heart failure. The patient received dialysis treatments in hospital for removal of fluid and was discharged with instruction to continue home hemodialysis treatments with nxstage products and therapy, for additional fluid removal.
 
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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
9786875276
MDR Report Key7845429
MDR Text Key119158519
Report Number3003464075-2018-00034
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberNX1000-3
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 Received08/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1
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