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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 11078002
Device Problems Increase in Pressure (1491); Failure to Prime (1492)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Event Description
Per bedside nursing, multiple (4 or 5) cvvh nx stage cartridges alarming "high pressure" when attempting to prime, despite different rns attempting and changing out the cvvh machine to a new one.Lot number pulled from cvicu and requested distribution to bring additional cartridges of a different lot to restock the cvicu for the night.Multiple issues over past couple of months with different lot numbers of nxstage cartridges - prior safety vents placed and awaiting further information from vendor through supply chain.At this time, cvicu have multiple cartridges sitting in our office area awaiting to be sent back to supply chain or directly to company.
 
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Brand Name
NXSTAGE CARTRIDGE
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
920 winter street
waltham MA 02451
MDR Report Key14619300
MDR Text Key293474465
Report Number14619300
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 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number11078002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/14/2022
Event Location Hospital
Date Report to Manufacturer06/07/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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