• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problems Charred (1086); Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
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) reported a discolored hemodialysis machine power plug. There were no diagnostic messages or audible alarms expected, and there was no problem with the machine. The biomed tech stated he found the discolored plug while performing preventative maintenance or servicing unrelated to the plug. The biomed tech stated that the issue has been resolved, the device is in service, and confirmed that there was no patient involvement. The inside of the plastic casing of each plug showed melting and charring. No spark, smoke, or flame from the plug was noticed. The sample was discarded and was no longer available for evaluation.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer (biomed tech) reported a discolored hemodialysis machine power plug. There were no diagnostic messages or audible alarms expected, and there was no problem with the machine. The biomed tech stated he found the discolored plug while performing preventative maintenance or servicing unrelated to the plug. The biomed tech stated that the issue has been resolved, the device is in service, and confirmed that there was no patient involvement. The inside of the plastic casing of each plug showed melting and charring. No spark, smoke, or flame from the plug was noticed. The sample was discarded and was no longer available for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HEMODIALYSIS SYS., WITH CDX
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 Key7161224
MDR Text Key280183149
Report Number2937457-2018-00040
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190713
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 Received01/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-