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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 Problems Thermal Decomposition of Device (1071); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 12/16/2017
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: although it was originally stated that the power cord/plug assembly was available to be returned to the manufacturer, no parts have been received by the manufacturer for evaluation to date. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). The reported burned 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
Additional information: device evaluation: the power supply cord and plug assembly was returned to the manufacturer for analysis. A visual examination was performed on the plug which revealed signs of discoloration from heat damage and arcing and pitting on the prongs (hot terminal and neutral terminal) of the plug. In addition, the clear molding of the plug appeared to have been melted. There were no discrepancies visible on the cable part of cord. Functional testing was performed by installing the returned cord and plug assembly into the power supply of a working test unit. The part was able to be installed without any problems. The plug was secured in the outlet and was not easily unplugged. The test unit powered on without any failures. There were no sparks observed. The test unit was able to complete the rinse program and the self-test program without any failures and without causing any further damages to the plug. A functional resistance test was performed on the plug by measuring the resistance between the three wires (hot, neutral, and ground). In addition, the continuity was measured from the prongs to the end of the wires. Each wire of the cord found no discrepancies. All three wires had continuity at 0. 2 ohms from end to end and the resistance was open, as expected. The investigation into the cause of the complaint was able to confirm the reported event. Although there were no observed sparks, a visual examination of the plug confirmed that the part sustained heat damage. Therefore, the complaint has been deemed confirmed.
 
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 2008k2 hemodialysis (hd) machine had a spark at the outlet during the cleaning program that was observed by a patient care technician (pct). There was no shock to the pct. 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 reportedly discolored, blackened, and charred, and there was scorching on the outlet plate where the machine plug was used. The machine did not give any alarms or power down. The plug was the original fresenius part on the machine. The biomed reported that there was no burning smell, smoke, or flame observed. The machine has approximately 20,348 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The outlet was replaced following the event. The biomed also replaced the power cord and plug assembly, which resolved the issue. The unit was returned to service at the user facility without a recurrence of the event as reported. The power cord and plug assembly was stated to be available to be returned to the manufacturer for physical 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
MDR Report Key7172958
MDR Text Key279908408
Report Number2937457-2018-00093
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K994267
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 02/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2018
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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