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

MAUDE Adverse Event Report: FRESENIUS USA, INC. 2008 SERIES HEMODIALYSIS MACHINES 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
 

FRESENIUS USA, INC. 2008 SERIES HEMODIALYSIS MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 2008K2
Device Problems Therapeutic or Diagnostic Output Failure (3023); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Insufficient Information (4580)
Event Date 11/09/2020
Event Type  malfunction  
Event Description
Patient regularly receives continuous renal replacement therapy (crrt) in his patient room. At approx. 0015 this am, i attempted to rinse back patient's treatment from crrt machine, as his 12-hour therapy was stated to terminate within the next 15 minutes. I was able to successfully rinse back his arterial side, but as soon as i switched over to rinse back the venous side, the screen of crrt machine froze and would not allow any inputs, resets, silencing, or rinsing back. Every imaginable intervention to rinse back the venous side was attempted, but my patient was unable to receive back the portion of his blood that was in the venous side of the machine. I informed md of what occurred, who voiced concerns about the patient continuing to receive crrt on that machine. I also consulted with the dialysis rn, who stated that in the case of what i experienced, there is no intervention that would have allowed me to rinse the rest of the blood back due to machine error. It is imperative that specific machine be replaced by a new machine in room prior to my patient receiving any more crrt.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008 SERIES HEMODIALYSIS MACHINES
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS USA, INC.
920 winter street
waltham MA 02451
MDR Report Key10851554
MDR Text Key216611571
Report Number10851554
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 11/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2008K2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2020
Event Location Hospital
Date Report to Manufacturer11/17/2020
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?
Type of Device Usage Unkown

-
-