• 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 HD SYS. CDX W/BIBAG BLUE STAR 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 HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191126
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a v104 stuck open alarm. Upon follow up, biomed confirmed the reported product complaint. Biomed stated that a 2008t machine was failing functional tests outside of therapy due to the v104 alarm. Biomed stated that upon troubleshooting the machine issue, the field service technician (fst) found that the ribbon cable on the bibag assembly was burned and a burning smell was detected at that time. Biomed did not observe any smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burned ribbon cable. Biomed could not confirm the machine hours but the cable and assembly were the original fresenius parts on the machine. Biomed reported the machine has not had any past problems with failing the electrical leakage test and is always plugged into a hospital grade ground fault circuit interrupter (gfci) outlet. Biomed stated that the entire bibag assembly including the cable was replaced by the fst, which resolved the machine issue, and that the machine is back in service without any issues. Additionally, biomend confirmed that there was no damage observed on any other components, or any other additional issues, associated with the burned cable. Biomed confirmed that a patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. Biomed confirmed that the fst picked up the damaged cable and assembly. Upon further follow up, the fst confirmed that the damaged part has been returned to the manufacturer for physical analysis.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HD SYS. CDX W/BIBAG BLUE STAR
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 Key12934597
MDR Text Key281752526
Report Number2937457-2021-02398
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102099
UDI-Public00840861102099
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 02/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2021
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-