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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE DIALYSIS MACHINE

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE DIALYSIS MACHINE Back to Search Results
Device Problems Disconnection (1171); No Fail-Safe Mechanism (2990); Device Handling Problem (3265)
Patient Problems Cardiac Arrest (1762); Irritation (1941); Blood Loss (2597)
Event Date 11/07/2019
Event Type  Death  
Event Description
Nxstage dialysis pt who performed dialysis treatment at home. Pre bp 166/61, pulse 101, temp 97. 1. At approx 1250 dialysis treatment was initiated via left upper arm avfistula with #15 gauge needles, arterial pressure -193, venous pressure 266, blood flow rate 450. Vital signs obtained approx every 30 mins. At approx 1515 arterial pressure -190, venous pressure 231, blood flow rate 450. At approx 1545 arterial pressure 4, venous pressure 140, blood flow rate 0. Patient was found by family member at undetermined time, with the fistula needle line disconnected from the dialysis line; 911 and cpr was initiated. Patient was transported to emergency room at approx 1640. Approx 3-4 liters of blood loss. Patient expired in emergency room.
 
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Brand NameNXSTAGE SYSTEM ONE
Type of DeviceDIALYSIS MACHINE
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
lawrence MA 01843
MDR Report Key9409485
MDR Text Key169044806
Report Number9409485
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 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/22/2019
Distributor Facility Aware Date11/08/2019
Event Location Home
Date Report to Manufacturer11/22/2019
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: 11/26/2019 Patient Sequence Number: 1
Treatment
1.0K 40 LACTATE DIALYSATE,; 15 GAUGE. ; 3M PRODUCTS: MICROPORE PAPER TAPE, ; FRESENIUS MEDICAL CARE PRODUCTS: NORMAL SALINE 1000 ML ; JMS PRODUCTS: JMS HARMONY FISTULA BUTTONHOLE NEEDLE,; MEDIPORE PLASTIC TAPE. ; NXSTAGE PRODUCTS: CARTRIDGE 170,; STREAMLINE EXPRESS BLOOD LINES.
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