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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number CAR-500
Device Problems Device Alarm System (1012); Leak/Splash (1354); Material Rupture (1546)
Patient Problem Blood Loss (2597)
Event Date 03/06/2020
Event Type  malfunction  
Event Description
While providing continuous renal replacement therapy (crrt) to the patient the continuous venovenous hemodiafiltration circuit started leaking.The therapy was stopped, circuit changed.The new circuit did not have any visible leaking, but the nxstage machine alarmed that there was a blood leak in the circuit.The trouble shooting process was initiated, but it didn't help.The machine kept alarming and therapy was stopped per procedure instruction.Manufacturer response for infusion device, crrt cycler (per site reporter).Cassette ruptured leaking dialysate from underneath unit.
 
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Brand Name
NXSTAGE SYSTEM ONE
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 Key9920554
MDR Text Key186299219
Report Number9920554
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 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCAR-500
Device Lot Number90678006
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2020
Event Location Hospital
Date Report to Manufacturer04/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17155 DA
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