• 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. NXSTAGE 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. NXSTAGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number NX1000-5-A
Device Problems Loose or Intermittent Connection (1371); Component Missing (2306); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2022
Event Type  malfunction  
Event Description
While nurse was touching display to do hourly numbers, the machine fell off the stand onto nurse. Nurse was able to stabilize the machine on a chair in the room and blood was returned to the patient safely. There was no injury to the nurse or the patient but therapy was interrupted. The machine is attached to the stand with three thumb nuts, two on the top and one on the bottom. All three nuts on this machine were missing and had apparently vibrated loose and fell off. Inspection of other machines found several loose or missing nuts. The machines are subject to frequent moving, including elevators, which can cause the nuts to loosen. The thumb nuts are intended to make servicing the machine easier, but don't have any kind of locking mechanism.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13710183
MDR Text Key286855718
Report Number13710183
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 Biomedical Engineer
Type of Report Initial
Report Date 02/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNX1000-5-A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/25/2022
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer03/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-