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U.S. Department of Health and Human Services

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

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NXSTAGE MEDICAL, INC. NXSTAGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 10178001
Device Problems Failure to Prime (1492); Deformation Due to Compressive Stress (2889); Filtration Problem (2941); Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2021
Event Type  malfunction  
Event Description
Patient is on cvvh. Blood returned at 1241. New filter would not prime, several kinks, did not appear to return back through micron filters, several balance pressure and increased access pressure alarms. Another reset attempt was done, and it would result in same increased balance chamber pressure, access pressures increased. Waste line did not appear to have fluid flowing in past the micron-filter at initiation. Lot number 10178001 and same issue with lot number 1278002. On third attempt with new lot number, it primed without issues. This was never attached to the patient; this is a delay in care and cvvh for renal function due to malfunctioning filter lots.
 
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Brand NameNXSTAGE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
MDR Report Key11869569
MDR Text Key252167275
Report Number11869569
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 04/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number10178001
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2021
Event Location Hospital
Date Report to Manufacturer05/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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