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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 False Alarm (1013); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2020
Event Type  malfunction  
Event Description
Cvvh machine would alarm "high balance chamber pressure" while priming new filters. Multiple filters used with different lot numbers. Lot numbers for filters are as followed: 00278006, 00778006. Cvvh machine was changed. Filter lot number 00678014 was inserted and the machine again alarmed with high balance chamber pressures and an additional alarm of "air in replacement fluid line" even though there was no visible air in the circuit. Each of these filters had to be discarded. The patient was absent from cvvh for between 4 to 5 hours.
 
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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 Key10677142
MDR Text Key211291391
Report Number10677142
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 09/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2020
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 FDA09/08/2020
Event Location Hospital
Date Report to Manufacturer10/14/2020
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?
Type of Device Usage Unkown

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