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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 06/02/2021
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 (bmt) reported that when moving the machine the power plug from a fresenius 2008t hemodialysis (hd) machine appeared melted.There was no patient involvement, no patient adverse effects were experienced, and no medical intervention was required.During troubleshooting, the bmt noticed that the power plug appeared melted near the prongs, with the plug exhibiting a orange-red hue.There was no burning smell, smoke or arcing noted, and there were no reports of sparks or flames.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing any electrical leakage test.The biomedical technician stated there were approximately 17,579 hours on the machine at the time of the event.To resolve the reported issue, the bmt replaced the power plug.The machine passed all testing and was returned to service.The power plug was available to be returned for evaluation as it was reportedly discarded.Photographs of the melted power plug were also not available.
 
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.
 
Event Description
A user facility biomedical technician (bmt) reported that when moving the machine the power plug from a fresenius 2008t hemodialysis (hd) machine appeared melted.There was no patient involvement, no patient adverse effects were experienced, and no medical intervention was required.During troubleshooting, the bmt noticed that the power plug appeared melted near the prongs, with the plug exhibiting a orange-red hue.There was no burning smell, smoke or arcing noted, and there were no reports of sparks or flames.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing any electrical leakage test.The biomedical technician stated there were approximately 17,579 hours on the machine at the time of the event.To resolve the reported issue, the bmt replaced the power plug.The machine passed all testing and was returned to service.The power plug was available to be returned for evaluation as it was reportedly discarded.Photographs of the melted power plug were also not available.There was no patient involvement associated with the reported event.
 
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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 Key11940165
MDR Text Key254820796
Report Number2937457-2021-01183
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 health professional,user faci
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 06/02/2021
Initial Date FDA Received06/04/2021
Supplement Dates Manufacturer Received06/16/2021
Supplement Dates FDA Received06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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