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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CYCLER S MACHINE NXSTAGE HOME HEMODIALYSIS MACHINE

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NXSTAGE MEDICAL, INC. NXSTAGE CYCLER S MACHINE NXSTAGE HOME HEMODIALYSIS MACHINE Back to Search Results
Model Number NX1000-3
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Exsanguination (1841); Myocardial Infarction (1969)
Event Date 09/25/2018
Event Type  Death  
Event Description
On the morning of (b)(6) 2018 during a nocturnal home hemodialysis treatment, the pt's enuresis alarm sounded, waking the pt's wife. This was approx 3. 5 hours into the scheduled 5 hour treatment. The pt's wife reported that upon hearing the alarm, she reached over to touch her husband, who was cold to touch. She got up, turned on the light and saw blood on the bed and floor. She called 911. She stated she clamped the venous line. Reportedly, when she clamped the venous line, the venous fistula needle popped out. Ems arrived and started cpr, which was stopped per wife's request. The police arrived, who called the pt's physician. The pt's wife reported that the pt was transported to the mortuary with the enuresis device still on his arm. Upon review of the dialysis treatment record, it was noted that numerous dialysis machine alarms requiring the pt reset the alarm before treatment could be resumed occurred throughout the entire treatment. The pt's wife reported to the home therapies staff that the venous needle was re-positioned during the treatment, time unk. Pt received 8000 unit heparin bolus upon initiation of treatment, and 1000 units/hour heparin infusion during the treatment.
 
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Brand NameNXSTAGE CYCLER S MACHINE
Type of DeviceNXSTAGE HOME HEMODIALYSIS MACHINE
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
lawrence MA 01843
MDR Report Key7957646
MDR Text Key123510771
Report Number7957646
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberNX1000-3
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/02/2018
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/09/2018
Distributor Facility Aware Date09/25/2018
Device Age9 MO
Event Location Home
Date Report to Manufacturer10/09/2018
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: 10/09/2018 Patient Sequence Number: 1
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