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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191126
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 01/16/2020
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. However, an on-site evaluation was performed by a fresenius field service technician (fst). To resolve the reported issue, the fst replaced the entire power supply. 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 identified 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 able to confirm the reported failure mode. During the device evaluation, the fresenius fst identified evidence of charring and melting on the machine's power plug. Therefore, the complaint event was confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that a fresenius 2008t machine powered down unexpectedly during the setup for a hemodialysis (hd) treatment. The machine operator performed a quick inspection of the device and noticed the power plug looked burnt and was hot to the touch. The machine was pulled from service for further examination and a fresenius field service technician (fst) was called onsite to perform an evaluation. During the evaluation, the fst reportedly found evidence of charring and melting on the power plug. Photos of the power plug were provided by the fst, and they validated the reported damage. One of the photos showed black residue which looks like it melted (from the power plug) and seeped into the power outlet, as described by the fst. The outlet was removed from the wall and replaced before the fst arrived at the unit. There was no smoke, burning smell, or arcing reported. Additionally, there were no reported sparks or flames. No other damaged components or parts were found. The fst stated the clinic does not utilize hospital grade ground-fault interrupter (gfci) outlets. It was recommended that they transition to this type of outlet. The fst also advised them to call an electrician onsite to evaluate the unit¿s electrical wiring. Upon follow up with the unit¿s biomed, it was confirmed that the machine had no previous history of failing the electrical leakage test. The fst replaced the entire power supply to resolve the reported issue. After the repair was completed, machine functional tests were performed, and they passed. The machine was subsequently returned to service. There was no patient involvement associated with the reported event. The fst stated the damaged power plug was available to be returned for evaluation, but to date, it has not been received by the manufacturer.
 
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Brand Name2008T HD SYS. 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 Key9673844
MDR Text Key177882509
Report Number2937457-2020-00251
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 04/21/2020
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 Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2019
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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