CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 2008T |
Device Problems
Thermal Decomposition of Device (1071); Charred (1086)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in progress.A supplemental medwatch report will be submitted at the completion of this activity.
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Event Description
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A user facility reported the machine had a flow recirc error 1 and a bibag: temp sensor alarm in heat disinfection mode.No patient involved as this occurred in heat disinfect.Reportedly, the bibag temp sensor alarm clears when the machine heats up to 80 degree celsius (c) while in heat disinfect.Follow-up was provided which revealed that a valve "shorted out" and the area where the valve connects was found to be blackened.Furthermore, the biomedical technician at the user facility confirmed this report and clarified the event.The biomed stated that valve 103, located in the bibag pump, was charred.Following the part replacement, the system was restored to full functionality.Functional testing performed by the biomed confirmed the system was operating properly.The unit has been returned to service at the user facility without issue.No parts are available to be returned to the manufacturer for evaluation.
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Manufacturer Narrative
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The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.Follow-up was provided by the biomedical technician who revealed that valve 103, located in the "bibag" pump, "shorted out" and the area where the valve connects was found to be blackened/charred.The biomed replaced valve 103 to resolve the issue.Following the part replacement, the system was restored to full functionality.Functional testing performed by the biomed confirmed the system was operating properly.The unit has been returned to service at the user facility without issue.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 associated with 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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