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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 Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Itching Sensation (1943); Loss of consciousness (2418)
Event Date 05/20/2019
Event Type  Injury  
Manufacturer Narrative
The involved cycler was not received for evaluation. A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. There is no information to indicate that a malfunction occurred. Udi #: (b)(4). This report and the information contained herein is submitted to the applicable competent authority under medical device directive 93/42/eec and represents the information available to the company at the time of the report.
 
Event Description
A report was received on (b)(6) 2019 from the nurse of a (b)(6) female with a medical history significant for hypertension, diabetes and itching prior to her hemodialysis treatment that day, who experienced worsened itching within approximately 4 minutes of initiating her first hemodialysis treatment on (b)(6) 2019. Treatment was terminated with rinseback after which the patient developed shortness of breath and became unresponsive. A pulse was present and emergency services were contacted who transported the patient to the hospital critical care unit with an admitting diagnosis of cardiac arrest. Additional information was received on (b)(6) 2019 from the nurse stating resuscitation efforts had been initiated prior to arrival of emergency services with cardiac arrest occurring en route to the hospital. Available information indicates the patient did not respond to resuscitative efforts with details of outcome requested but not 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 Key8684218
MDR Text Key147571177
Report Number3003464075-2019-00027
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 01/01/2005,06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
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 Received05/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/10/2019 Patient Sequence Number: 1
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