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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Break (1069); Fluid Leak (1250); Gas Leak (2946)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/08/2021
Event Type  malfunction  
Event Description
Primary and secondary rn at bedside along with perfusionist attempting to trouble shoot cvvh (which was hooked up to the ecmo circuit) pressure issues, when secondary rn heard air in the pump head. Perfusionist immediately clamped "venous" and "arterial" cvvh lines and then clamped ecmo circuit. Secondary rn got cca to bedside while perfusion attempted to de-air the circuit. Situation progressed to code. During code, after the first de-airing, perfusionist attempted to restart ecmo, but more air got into the circuit. It was then noted that there was blood on the floor as well. Upon further inspection of the cvvh connection the clear plastic tubing had broken off of the blue connector, connecting it to the ecmo. Ecmo side port stopcock turned off and circuit successfully deaired and restarted.
 
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Brand NameNXSTAGE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
MDR Report Key11581196
MDR Text Key242702797
Report Number11581196
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/09/2021
Event Location Hospital
Date Report to Manufacturer03/29/2021
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 Unkown

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