• 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 SYS., WITH CDX 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 SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problems Thermal Decomposition of Device (1071); Charred (1086); Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 12/27/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: there was no on-site evaluation of the unit performed by a fresenius regional equipment specialist (res). The user facility biomedical technician (biomed) replaced the distribution board, which resolved the issue. The unit was returned to service at the user facility without a recurrence of the event as reported. The distribution board was returned to the manufacturer for physical evaluation. However, the evaluation has not yet been completed. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances or any associated rework during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident will be reached following a completed physical examination of the complaint device.
 
Manufacturer Narrative
Additional information and device evaluation: the distribution board was returned to the manufacturer for analysis. A visual examination was performed on the distribution board which revealed signs of heat damage on terminal block k2 and on the back of the distribution board where terminal block k2 connects. Terminal block k2 was also cracked, and internal damage was visible on terminal blocks k1 and k2, which are right next to each other. A functional resistance test was performed on the distribution board by measuring the resistance between blocks k1 and k2. There were no discrepancies found. All measurements found the resistance to be open, as expected. The damaged terminal blocks k1 and k2 were replaced on the distribution board in order to complete functional testing. The repaired distribution board was able to be installed into a working test unit. The test unit was powered on without any failures. The test unit was able to complete the rinse, self-test, dialysis, and heat disinfect programs without any failures or alarms. The testing did not cause any further damage to the distribution board. The temperature was stable at 36. 7°c during testing. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances or any associated rework during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was able to confirm the reported event. Visual examination of the distribution board confirmed that the part sustained heat damage. Therefore, the complaint has been deemed confirmed.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
A biomedical engineer (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine had a burned distribution board. The machine had been removed from service due to an issue with fluctuating temperature during set-up mode. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals due to this event. The biomed stated that there was burning smell coming from the distribution board and the heater block on the distribution board was melted, charred, and blackened. There was no smoke, flame, or spark reported. The distribution board was the original part on the machine. The machine has approximately 800 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed replaced the distribution board, which resolved the issue. The unit was returned to service at the user facility without a recurrence of the event as reported. The distribution board was stated to be available to be returned to the manufacturer for physical evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HEMODIALYSIS SYS., WITH CDX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key7185284
MDR Text Key195190918
Report Number2937457-2018-00152
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2018
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received03/23/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-