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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 Backflow (1064); Mechanical Problem (1384); Reflux within Device (1522)
Patient Problem No Patient Involvement (2645)
Event Date 04/08/2019
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 biomedical technician (biomed) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill during set-up for use. The backfill was visually observed by staff. The biomed did not report that there were any machine alarms. A patient was not connected to the machine at the time of the incident. The biomed reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification. The biomed believes the saline bag backfill was not due to user error. The biomed confirmed that the unit has received the cbe hardware and software upgrades. The biomed advised he replaced the air separator board and rebuilt valve 24 to resolve the issue and return the machine to service. The machine is back in service without reoccurrence of the reported event. No parts are available for return to the manufacturer.
 
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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
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 Key8509995
MDR Text Key141789211
Report Number2937457-2019-01097
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 04/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190371
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received04/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2007
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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