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

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG 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
 

CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190766
Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
Biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine began to smoke and smell and then powered off 10 minutes prior to the completion of a patient¿s treatment. The machine was pulled from service and the cause of the event was traced to a melted valve (#105). The machine has approximately 14,652 hours and the valve was the original fresenius part on the machine. The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with valve 105. The biomed replaced valve 105, which resolved the issue, as well as the bibag assembly during the course of troubleshooting. Follow-up with the user facility clinical manager (cm) confirmed that the patient did not experience a serious injury, adverse event, or require medical intervention as a result of the reported issue. The patient completed treatment approximately 10 minutes early and was able to be reinfused to prevent blood loss. The unit was repaired but remains out of service pending bleach disinfection. The valve is available to be returned to the manufacturer for physical evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key13662304
MDR Text Key286641137
Report Number2937457-2022-00343
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190766
Device Catalogue Number190766
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-