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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number CAR-500
Device Problems Computer Software Problem (1112); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2022
Event Type  malfunction  
Event Description
Patient requires continuous dialysis (cvvh), which is connected to our ecmo circuit.Without warning, apparent cause, or prior alarms, cvvh alarmed "terminate treatment immediately: balance chamber system failure." rn was unable to troubleshooting, or utilize the buttons on the device.Rn was forced to return blood manually (via squeezing attached normal saline bag) from the cvvh through the ecmo circuit and back to the patient.Unsure whether the issue was related to the cvvh machine, or the cartridge/filter.Filter ref car-500, lot 10778017.
 
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Brand Name
NXSTAGE CARTRIDGE EXPRESS
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 Key15787737
MDR Text Key303556859
Report Number15787737
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 09/29/2022
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 Health Professional
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Device Lot Number10778017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2022
Event Location Hospital
Date Report to Manufacturer11/14/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/14/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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