CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 190713 |
Device Problems
Charred (1086); Melted (1385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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A biomedical engineer (biomed tech) reported a discolored hemodialysis machine power plug.There were no diagnostic messages or audible alarms expected, and there was no problem with the machine.The biomed tech stated he found the discolored plug while performing preventative maintenance or servicing unrelated to the plug.The biomed tech stated that the issue has been resolved, the device is in service, and confirmed that there was no patient involvement.The inside of the plastic casing of each plug showed melting and charring.No spark, smoke, or flame from the plug was noticed.The sample was discarded and was no longer available for evaluation.
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Manufacturer Narrative
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Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
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Event Description
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A biomedical engineer (biomed tech) reported a discolored hemodialysis machine power plug.There were no diagnostic messages or audible alarms expected, and there was no problem with the machine.The biomed tech stated he found the discolored plug while performing preventative maintenance or servicing unrelated to the plug.The biomed tech stated that the issue has been resolved, the device is in service, and confirmed that there was no patient involvement.The inside of the plastic casing of each plug showed melting and charring.No spark, smoke, or flame from the plug was noticed.The sample was discarded and was no longer available for evaluation.
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Search Alerts/Recalls
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