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U.S. Department of Health and Human Services

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

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NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE PUREMA DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 10978013
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2022
Event Type  malfunction  
Event Description
During treatment, therapy fluid was noted to be leaking from the cartridge used for nxstage continuous renal replacement therapy (crrt). After blood was returned to the patient and the cartridge removed, a puncture/tear was found in the plastic lining of the cartridge. The machine is not believed to have malfunctioned, it had been in regular use for weeks. The cartridge had been used for approximately 12 hours before the leak began.
 
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Brand NameNXSTAGE CARTRIDGE PUREMA
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
MDR Report Key13808835
MDR Text Key287553149
Report NumberMW5108235
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number10978013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

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