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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

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190713
Device Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported to fresenius technical support that a 2008t hemodialysis (hd) machine sustained thermal damage. The biomed stated the machine initially had an eeprom error, and the eeprom was then replaced. During the machines temperature control calibration, a low temperature error occurred. The power supply was swapped out with a spare power supply and the heater rod was replaced; however, the low temperature issue persisted. Next, they swapped out the power logic board with a known good one from a different machine. After doing so, on power-up, a tiny puff of smoke which lasted for a split second was noted. The machine was immediately powered off. A burning smell was also noticed. Upon further inspection, thermal damage was found on ic17 and ic12 of the power logic board. The biomed stated the board was slightly blackened in the area near those chips. To resolve the reported issue, the biomed replaced the power logic board and the power supply. The machine was then recalibrated and returned to service. The biomed confirmed there were no signs of any sparks, flames, melting, or arcing. No damage was identified on any other components. The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test. The biomed stated the machine had approximately 11,879 hours on it. The power logic board and power supply were both available to be returned for evaluation. The biomed stated they would return them for physical evaluation via the returned goods authorization (rga) process. There was no patient involvement associated with the reported event.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key12523037
MDR Text Key273063137
Report Number2937457-2021-01945
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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