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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); Fire (1245); Smoking (1585); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 01/16/2020
Event Type  malfunction  
Manufacturer Narrative
This complaint captures one of two events that were reported against the same device, please see associated mdr (mfr report #: 2937457-2020-00249). The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A biomedical technician (biomed) was performing a semi-annual preventive maintenance (pm) check on a fresenius 2008k2 hemodialysis (hd) machine when an ¿acid pump no end of stroke (eos)¿ message was displayed. The message was displayed on power up. The biomed stated there was a burning smell that followed. The biomed shut down the machine and attempted to locate the origin of the burning smell; nothing could be found. The biomed then replaced the acid pump which failed to resolve the reported issue; the no eos message continued to appear. The biomed then replaced the actuator test board with a brand new one. After replacing the actuator test board, the biomed powered up the machine with the card cage open to have visibility of the board. When the machine was moved into rinse mode, a spark was observed coming from the actuator test board, followed by a small flame that extinguished within a second, and then a small cloud of smoke. The smoke detectors did not go off. The biomed removed the second actuator board to inspect it for damage, and burn marks were noted on the ic19 and ic23 chips. The biomed then looked at the first actuator test board and verified that there were burn marks on the same chips. The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test. Upon follow up with the biomed, it was confirmed that there was no patient involvement associated with the reported events. The machine remains out of service as the biomed is waiting on a replacement actuator board for installation. It was also reported that the biomed only visits the clinic once a quarter. The actuator test boards are reportedly available for evaluation, and the biomed intends to send them back to the manufacturer. This report captures the spark, small flame, and cloud of smoke that came from the second actuator test board, in addition to burn marks on the 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
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 Key9673432
MDR Text Key177865453
Report Number2937457-2020-00250
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2020
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? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/12/2020
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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