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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 Mechanical Problem (1384); Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
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) biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008k2 hd machine was giving a filling program message in setup and the saline bag was filling. During follow-up, the biomed confirmed being told that a saline bag backfill had occurred during priming. The biomed was unable to speak directly with the staff member who saw this happen. Furthermore, the biomed reported this individual was no longer employed at the facility which hindered their ability to properly troubleshoot the issue. The biomed could not confirm what the staff member did or did not see. They could not confirm if the individual visually observed the saline bag refilling with dialysate. The biomed confirmed the drain line length and height were within specification and stated there were no quick disconnects used on the drain line. The biomed did not know if the saline bag backfill was due to use error. Upon completion of their machine evaluation, the biomed concluded that ¿the air separator was not doing its job¿. They replaced the air separator to resolve the reported issue. The biomed was aware that a cbe software upgrade had to be performed on the machine, and they confirmed receiving the upgrade kit which was ordered during a separate call to ts. At the time of follow-up, the biomed acknowledged that the upgrade still needed to be performed. The machine was tested and primed with saline prior to being returned to service and the issue did not reoccur. No further issues have been reported on the machine, and no parts were available to be returned for manufacturer evaluation. There was no patient involvement associated with the reported issue.
 
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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 Key11632055
MDR Text Key244664476
Report Number2937457-2021-00630
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 04/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
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 Received04/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2010
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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