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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190766
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 01/21/2020
Event Type  malfunction  
Manufacturer Narrative
This complaint captures one of three events that were reported against the same device, please see associated mdr's (mfr report #'s: 2937457-2020-00271 and 2937457-2020-00272). 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 a fresenius 2008t machine was pulled from service due to a valve 104/108 stuck closed message and the machine would not disinfect. During troubleshooting of the machine, the biomed attempted to rebuild the bicarb pump, however the bicarb pump wouldn't calibrate. The bicarb pump was replaced with a new one and it still would not calibrate. At this point, the biomed tried to resolve the issue by replacing the actuator test board. After doing so, a no end of stroke (eos) alarm appeared. Within seconds of installing the replacement actuator test board, a popping sound was heard followed by a burning smell. Upon inspection of the actuator test board, charring was found on the part. A total of three actuator test boards were installed and all three installations resulted in the same popping sounds, burning smell, and visible charring. Each actuator test board exhibited charring in a different location. The third actuator board that was installed displayed evidence of melting on one of the board chips. The biomed stated the electric wiring was assessed and confirmed to be adequate, and reported there was no debris found in the card cage. There were no visible sparks, flames, smoking or arcing. All actuator boards were discarded. The machine remained out of service until a fresenius field service technician (fst) was called onsite. The fst found the eeprom on the function board was not properly seated. The fst reseated the eeprom along with all other modules, one at a time. In addition, the fst replaced the motherboard. These repairs resolved the reported issue. After the repair, the fst performed functional tests on the machine and the machine passed all tests. 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 the machine was returned to service and has not experienced any further issues. There was no patient involvement associated with the reported event. This report captures the third of three events that were reported against the same device.
 
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Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
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 Key9690901
MDR Text Key178499947
Report Number2937457-2020-00273
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
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 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190766
Device Catalogue Number190766
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 Received02/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2016
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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