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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 Thermal Decomposition of Device (1071); Smoking (1585); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 12/21/2017
Event Type  malfunction  
Event Description
The biomedical engineer (biomed) was able to replace the power cord on the machine.
 
Manufacturer Narrative
Additional information: device evaluation: 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). 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. Although the customer provided a photograph of the reported damaged power plug, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
The biomedical engineer (biomed) reportedly received the replacement cord and plug assembly, but had not been able to install it on the machine yet and will plan with the area technical operations manager (atom) a time that the repair can be completed.
 
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 burned and discolored power plug. This was observed during inspection of the plug end when the machine was powered on. 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 plug was the original fresenius part on the machine. The biomed reported that there was no burning smell; however, there were at least two outlets that had burn damage and there was observed smoke and spark. The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed stated o be ordering a replacement cord and plug assembly. The biomed stated that the machine is currently in service at the user facility with the damaged plug. No parts were stated to be available to be returned to the manufacturer for physical evaluation at this time.
 
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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 Key7181609
MDR Text Key123886798
Report Number2937457-2018-00132
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,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2018
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 Received02/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

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