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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL INC. NXSTAGE NXSTAGE CYCLER

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NXSTAGE MEDICAL INC. NXSTAGE NXSTAGE CYCLER Back to Search Results
Device Problem Air/Gas in Device (4062)
Patient Problem Dyspnea (1816)
Event Date 10/04/2021
Event Type  Death  
Event Description
Home hemodialysis pt on nxstage machine with care partner. Care partner reported that immediately after treatment began, pt began to complain of shortness of breath. Care partner reported alarm 10 sounded. Alarm 10 button was muted and button to bypass alarm was pressed. Pt did not recover. Pt expired (b)(6) 2021.
 
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Brand NameNXSTAGE
Type of DeviceNXSTAGE CYCLER
Manufacturer (Section D)
NXSTAGE MEDICAL INC.
lawrence MA 01843
MDR Report Key12712858
MDR Text Key278974477
Report Number12712858
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/19/2021,10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/19/2021
Distributor Facility Aware Date10/04/2021
Event Location Home
Date Report to Manufacturer10/19/2021
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/19/2021 Patient Sequence Number: 1
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