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U.S. Department of Health and Human Services

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

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NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE FILTER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number CAR-500
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2023
Event Type  malfunction  
Event Description
Patient nxstage continuous veno-venous hemofiltration (cvvh) filter pulling air and unable to flow greater than 2.1l/min per bedside rn.
 
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Brand Name
NXSTAGE CARTRIDGE FILTER
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 Key16435153
MDR Text Key310146461
Report Number16435153
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 02/13/2023
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 Health Professional
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/13/2023
Event Location Hospital
Date Report to Manufacturer02/24/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/24/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23360 DA
Patient SexFemale
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