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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 Syncope (1610); Fall (1848); Loss of consciousness (2418)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
The device has not been received for evaluation and a serial number was not provided. Without a serial number, a review of the device history record (dhr) cannot be performed. There is no information to indicate that a malfunction or unexpected device behavior occurred. Although requested, no further information has been provided.
 
Event Description
A report was received on 12 may 2020 from a health care professional, regarding a patient weighing 72kg with end stage renal disease who lost consciousness and fell during a home hemodialysis treatment on (b)(6) 2020. Treatment was terminated with partial rinseback and the patient was disconnected from the cycler. Emergency services transported the patient to hospital where they were diagnosed with syncope and hospitalized. The patient's condition is improving. Treatment details, date of discharge and discharge diagnosis were requested and have not been provided.
 
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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 Key10134353
MDR Text Key194604354
Report Number3003464075-2020-00027
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeSP
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
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?
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 Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/09/2020 Patient Sequence Number: 1
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