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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. DIALYZER, HIGH PERMEABILITY, SYSTEM

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NXSTAGE MEDICAL, INC. DIALYZER, HIGH PERMEABILITY, SYSTEM Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 10/12/2017
Event Type  malfunction  
Event Description
Patient was receiving crrt treatment with no difficulties or issues. Five hours into treatment, crrt machine alarmed a green alarm with "looking for cycler" and error 901 in the right hand corner of the cycler. All pumps turned off at that time. The rn followed directions to restart cycler, and continued treatment for 5 minutes, then the machine alarmed again "looking for cycler". Blood manually returned, and nxstage called. The rn was guided through restart with nxstage, and cycler restarted and treatment resumed. An hour later, crrt machine alarmed "looking for cycler", blood manually returned, and crrt machine pulled out of operation. Per nxstage technician "not sure what would cause error 901".
 
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Type of DeviceDIALYZER, HIGH PERMEABILITY, SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack st
lawrence MA 01843
MDR Report Key6993414
MDR Text Key90785926
Report Number6993414
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
Type of Report Initial
Report Date 10/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2017
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2017
Event Location Hospital
Date Report to Manufacturer10/18/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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