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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190371
Device Problems Arcing (2583); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 08/25/2020
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 a fresenius 2008k hemodialysis (hd) machine experienced blown fuses during power up. Upon follow-up, it was reported that the issue occurred during a preventive maintenance (pm) check; there was no patient involvement. The blown fuses, which resulted in sparking and arcing, were traced to the machine¿s power control board. According to the biomed, the fuses had blown due to a faulty bridge rectifier. It was reported that part of a fuse enclosure had ¿snapped off¿ the power control board. To resolve the reported issue the biomed replaced both the power control board and the bridge rectifier. There were no burn marks noted on the parts, and there were no signs of charring, melting, smoke, or flames. After completing the repair, the biomed stated the machine was able to power on without issue. At the time of follow up, the machine was still undergoing the pm check. No damage was identified on any other components. The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed was unsure if the machine had any previous history of failing the electrical leakage test; however, they stated the power control board was an original (fresenius) part dated from 2003. This led them to believe there haven't been any electrical leakage failures because the power board is typically replaced when electrical leaks are identified. The biomed stated there were 19,737 hours on the machine. The bridge rectifier was discarded. The power control board was available to be returned for evaluation. The biomed stated they would contact technical support to set up returned goods authorization (rga) request.
 
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Brand Name2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
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 Key10544205
MDR Text Key207294169
Report Number2937457-2020-01673
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,Followup
Report Date 12/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number190371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2005
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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