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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
Model Number 190610
Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 05/13/2020
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 that they have replaced the acid pump and the actuator-test board twice and they burned up when the machine was plugged in. At that point in time, the fresenius technical support representative advised the biomed to swap the motherboard, actuator cable, and advised it could be a possible distribution board issue. Upon follow-up, the biomed stated that there were indications of a burning smell, smoke, and sparking. The biomed confirmed that the smoke detectors at the facility did not alarm. The issue was discovered during normal inspection. The machine has approximately 4,200 hours and actuator board is the original fresenius part. There were no past problems with the machine failing the electrical leakage test. The biomed stated that that a wire was damaged when the board was removed because it was caught on a screw which is believed to be the reason for the thermal event. The biomed stated that the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed confirmed that the actuator board has been replaced and the damaged wire cable was spliced back to rectify the issue. The machine is back in service without reoccurrence of the reported event. The biomed confirmed 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. The complaint device is not available to be returned to the manufacturer for physical evaluation because it was discarded.
 
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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
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 Key10102830
MDR Text Key192996575
Report Number2937457-2020-00960
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 user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190610
Device Catalogue Number190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2012
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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