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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191130
Device Problems Thermal Decomposition of Device (1071); Arcing (2583)
Patient Problem No Patient Involvement (2645)
Event Date 10/07/2020
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 hemodialysis (hd) user facility requested onsite service from a fresenius field service technician (fst) to repair a 2008t machine that was experiencing temperature control issues. The facility was reportedly having trouble increasing the temperature on the machine. The machine was out of service when the fst arrived at the facility, but it was plugged in. After removing the plug from the wall outlet, the fst immediately noticed signs of arcing. They noted evidence of charring stating that it looked like carbon was present in the molded piece of the plug. Upon further investigation, while inspecting the distribution box the fst identified a brown wire on the heater bar that was completely burnt. Based on what they found, the fst thinks the wire was damaged by a current surge that originated at the power plug. The temperature control issue was directly linked to the failed wire connection to the heater bar. The fst cut back the damaged section of the wire, and then resoldered and reconnected it. The fst also replaced the power cord on the machine. After completing the repair work, they power cycled the system multiple times and put the machine through heat disinfect. The temperature control issue was resolved. The machine subsequently passed all functional checks and was put back in service prior to the fst's departure. The damaged power cord/plug was reportedly returned to the manufacturer for evaluation. There was no evidence of any sparks, flames, melting, or burning smell. The machine had 973 hours on it at the time of the repair. No damage was identified on any other components. 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. There was no patient involvement associated with the reported event.
 
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Brand Name2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
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 Key10738135
MDR Text Key213154867
Report Number2937457-2020-01936
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
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 11/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number191130
Device Catalogue Number191130
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 Received11/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2020
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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