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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-505
Device Problem Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2020
Event Type  malfunction  
Event Description
This patient is on continuous veno-venous hemodialysis multiple high pressure/fluid balance pressure alarms (38) noted without kink/clots in system system/cartridge change to different lot with improvement (affected cartridge car 505; lot #00178005; exp 10-1-2021).Event happened with a second patient in the micu with same cartridge number.Manufacturer response for nxstage cvvh cartridge, acute care cartridges for renal replacement therapy (rrt) and therapeutic plasma exchange (tpe) (per site reporter).Our material management department went to the critical care unit and retrieved the cartridge(s).The local representative was informed and came on site to get the cartridge (no further insights).
 
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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.
350 merrimack st
lawrence MA 01843
MDR Report Key9981048
MDR Text Key188355146
Report Number9981048
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 Other Health Care Professional
Type of Report Initial
Report Date 04/16/2020,04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCAR-505
Device Lot Number#00178005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/16/2020
Event Location Hospital
Date Report to Manufacturer04/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age29200 DA
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