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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 11/10/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the power supply was returned to the manufacturer for analysis. A visual inspection of the power control board revealed signs of heat damage and charred marks on resistors r10 and r11. There was observed charred marks on the other components around the damaged resistors, however, there was no indication of heat damage. No other discrepancies were observed on any of the other components on the power supply. An inspection on the power supply cable and power plug found no damages. Functional testing was performed by installing the received power supply into a working unit. The test unit powered on without any alarms or failures. The unit was placed into dialysis mode and observed. The temperature remained high (high temperature alarm) during dialysis mode. The power control board did not sustain any further damage during the testing. The heat damage on resistors r10 and r11 is a known indication of an ¿open¿ triac, which is known to cause temperature failures while damaging resistors r10 and r11. Resistors r10 and r11 are within the triac circuit. The damaged resistors r10 and r11 were replaced on the power control board. The resistance was measured on each line of the triac circuit and were ¿open¿. The triac from location mt1 to gate should not read as open. The triac was then replaced with a working triac. The functional test was re-run with the repaired power supply and no failures or alarms were encountered. The investigation into the cause of the problem was able to confirm the reported event. The evaluation of the complaint device by the manufacturer confirmed visual burn damage to the power logic board and functional testing confirmed that the resistors r10 and r11 sustained heat damage. Therefore, the complaint has been deemed confirmed.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). The unit was pulled from service for evaluation by the facility biomedical engineer (biomed) following the event. The biomed ordered a power supply to resolve the issue. The machine is currently out of service. 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 cannot be reached without a physical examination of the complaint device.
 
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 2008k2 hemodialysis (hd) machine had been removed from service due to fluctuating temperature and high temperature alarms during set-up. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals as a result of this malfunction. During troubleshooting, the biomed observed discolored and burned resistors #10 and #11 on the power control board. The biomed stated that near these resistors were burned and blackened areas with black soot. There was no damage noted on any other components. There was no burning smell, smoke, flame, or spark reported. The power control board was the original fresenius machine part. The biomed replaced the power control board with a new fresenius board. When the new part was installed and the machine turned on, the biomed immediately smelled a burning smell and saw visible smoke and spark. There was no actual flame or fire. The biomed turned the machine off and the power control board displayed the same burn damage as the first board, which blackening at resistors #10 and #11. The biomed order a power supply to resolve the issue. The machine is currently out of service. No parts have been made available to be returned to the manufacturer for evaluation at this time. This submission is being filed for the second event of visible smoke and spark with burn damage observed on the replacement power control board.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7082585
MDR Text Key269733910
Report Number2937457-2017-01293
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2010
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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