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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE NXSTAGE CVVH FILTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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NXSTAGE NXSTAGE CVVH FILTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 10478022
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
Event Type  malfunction  
Event Description
When priming cvvh filter, the rn noted the cvvh filter had two pin sized holes in the ¿bubbles¿ that go on the inside of the machine. The rn circled the spots on the filter and set filter aside for review. This delayed the patient getting dialysis in timely manner as a new filter needed to be primed.
 
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Brand NameNXSTAGE CVVH FILTER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE
350 merrimack street
lawrence MA 01843
MDR Report Key12868675
MDR Text Key281207362
Report Number12868675
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 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number10478022
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 FDA10/11/2021
Event Location Hospital
Date Report to Manufacturer11/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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