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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
Catalog Number 190610
Device Problem Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2017
Event Type  malfunction  
Manufacturer Narrative
Occupation: health care professional. Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed. However, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure. A device is not released if it does not meet requirements or is nonconforming. In addition, the device record review confirmed the labeling, material, and process controls were within specification.
 
Event Description
A biomedical engineer (biomed tech) stated that during maintenance the pre-conductivity cell had a melted dielectric and exposed wire. The biomed tech and there was no patient involvement and stated the machine was removed from service and the conductivity cell was going to be replaced for the machine. No visible smoke, flames or sparks were observed or noted. The machine currently was out of service, and once repaired and is qc tested the machine was to be placed back in service. No sample was available to be returned for evaluation.
 
Manufacturer Narrative
Kdi - dialyzer, high permeability with or without sealed dialysate system.
 
Event Description
A biomedical engineer (biomed tech) stated that during maintenance the pre-conductivity cell had a melted dielectric and exposed wire. The biomed tech and there was no patient involvement and stated the machine was removed from service and the conductivity cell was going to be replaced for the machine. No visible smoke, flames or sparks were observed or noted. The machine currently was out of service, and once repaired and is qc tested the machine was to be placed back in service. No sample was available to be returned for evaluation.
 
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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
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7068726
MDR Text Key253993777
Report Number2937457-2017-01264
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received04/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2009
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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