• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NXSTAGE MEDICAL, INC. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 42507
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2020
Event Type  malfunction  
Event Description
Nurse was attempting to return blood from the continuous veno-venous hemodialysis (cvvh) machine due to it being time to change the filter. Cvvh machine alarming "911 and system failure" and would not allow the nurse to return the blood to the patient. The prompts on the screen were to turn the machine on/off quickly. Once that was completed, the nurse attempted to return the blood a second time and again the cvvh machine alarmed "911/system failure. " the nurse was unable to return the blood to the patient due to it being clotted off by the time manual return could occur. The machine number is 42507. The lot number for the filter is 91278003.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10167138
MDR Text Key195550543
Report Number10167138
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 05/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42507
Device Lot Number91278003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/14/2020
Event Location Hospital
Date Report to Manufacturer06/18/2020
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

-
-