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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
Model Number 190713
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported that a 2008t machine was failing tmp tests.Biomed is still troubleshooting the reported issue and stated the machine is still out of service.The check valve, the dialysate pressure transducer #9, along with a few other parts have been replaced and the venous pressure was calibrated but none of those resolved the reported issue.The tech explained they saw, on top of the balancing chamber, that a valve (possibly a solenoid valve) had melted.Upon follow up, biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.Biomed stated that the machine has approximately 13,000 hours and that the valve is the original fresenius part on the machine.Biomed stated that the entire balance chamber was replaced, however the machine is still failing tmp tests for hi and low, and that the machine is not back in service.Additionally, biomed confirmed that there was no damage observed on any other components.Biomed confirmed that the machine has had not problems with passing electrical leakage tests and is plugged into a hospital grade ground fault circuit interrupter (gfci) outlet.Biomed confirmed that 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 malfunction.Biomed confirmed that the balance chamber and valve were discarded and are not available for return to the manufacturer for physical evaluation.
 
Event Description
A user facility biomedical technician (biomed) reported that a 2008t machine was failing tmp tests.Biomed is still troubleshooting the reported issue and stated the machine is still out of service.The check valve, the dialysate pressure transducer #9, along with a few other parts have been replaced and the venous pressure was calibrated but none of those resolved the reported issue.The tech explained they saw, on top of the balancing chamber, that a valve (possibly a solenoid valve) had melted.Upon follow up, biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.Biomed stated that the machine has approximately 13,000 hours and that the valve is the original fresenius part on the machine.Biomed stated that the entire balance chamber was replaced, however the machine is still failing tmp tests for hi and low, and that the machine is not back in service.Additionally, biomed confirmed that there was no damage observed on any other components.Biomed confirmed that the machine has had not problems with passing electrical leakage tests and is plugged into a hospital grade ground fault circuit interrupter (gfci) outlet.Biomed confirmed that 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 malfunction.Biomed confirmed that the balance chamber and valve were discarded and are not available for return to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 identified 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
Correction: h10 plant investigation correction plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 identified 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 reported event was confirmed based on the provided photograph.
 
Event Description
A user facility biomedical technician (biomed) reported that a 2008t machine was failing tmp tests.Biomed is still troubleshooting the reported issue and stated the machine is still out of service.The check valve, the dialysate pressure transducer #9, along with a few other parts have been replaced and the venous pressure was calibrated but none of those resolved the reported issue.The tech explained they saw, on top of the balancing chamber, that a valve (possibly a solenoid valve) had melted.Upon follow up, biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.Biomed stated that the machine has approximately 13,000 hours and that the valve is the original fresenius part on the machine.Biomed stated that the entire balance chamber was replaced, however the machine is still failing tmp tests for hi and low, and that the machine is not back in service.Additionally, biomed confirmed that there was no damage observed on any other components.Biomed confirmed that the machine has had not problems with passing electrical leakage tests and is plugged into a hospital grade ground fault circuit interrupter (gfci) outlet.Biomed confirmed that 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 malfunction.Biomed confirmed that the balance chamber and valve were discarded and are not available for return to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Correction: h6 investigation findings, investigation conclusions.
 
Event Description
A user facility biomedical technician (biomed) reported that a 2008t machine was failing tmp tests.Biomed is still troubleshooting the reported issue and stated the machine is still out of service.The check valve, the dialysate pressure transducer #9, along with a few other parts have been replaced and the venous pressure was calibrated but none of those resolved the reported issue.The tech explained they saw, on top of the balancing chamber, that a valve (possibly a solenoid valve) had melted.Upon follow up, biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.Biomed stated that the machine has approximately 13,000 hours and that the valve is the original fresenius part on the machine.Biomed stated that the entire balance chamber was replaced, however the machine is still failing tmp tests for hi and low, and that the machine is not back in service.Additionally, biomed confirmed that there was no damage observed on any other components.Biomed confirmed that the machine has had not problems with passing electrical leakage tests and is plugged into a hospital grade ground fault circuit interrupter (gfci) outlet.Biomed confirmed that 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 malfunction.Biomed confirmed that the balance chamber and valve were discarded and are not available for return to the manufacturer for physical evaluation.
 
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Brand Name
2008T HEMODIALYSIS SYS., WITH CDX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
MDR Report Key12350614
MDR Text Key267561725
Report Number2937457-2021-01750
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100897
UDI-Public00840861100897
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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