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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

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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: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). The reported melted and charred power plug was replaced by the biomedical technician (biomed) to resolve the issue. Following parts replacement, the unit was returned to service at the user facility without a recurrence of the event as reported. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances or any associated rework during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
A biomedical engineer (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine had a discolored power plug which was observed during preventative maintenance or servicing the machine unrelated to the plug. The inside of the plastic casing of the plug was reportedly melted and charred. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this event. The biomed reported that there was no smoke, spark or flame observed. The biomed replaced the power plug assembly, which resolved the issue. The unit was returned to service at the user facility without a recurrence of the event as reported. No parts are available to be returned to the manufacturer for physical evaluation.
 
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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
MDR Report Key7164070
MDR Text Key280467099
Report Number2937457-2018-00060
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2018
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
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received01/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

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