CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 2008T |
Device Problems
Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/14/2017 |
Event Type
malfunction
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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 received which revealed that the air separator adaptor board and valve 43 were replaced, but the issue remained.The system was powered down, and allowed to sit for a little while.After returning to run additional diagnostic tests, the issue was not able to be duplicated.The unit has been 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 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.The reported event of saline bag backfilled during recirculation was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Event Description
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The user facility reported that a saline bag backfilled while the 2008t hemodialysis (hd) machine was being prepared for use.No patient was connected to the system at the time of the incident.Follow-up was received which revealed that the unit had received the cbe upgrade prior to this event.During troubleshooting, the air separator adaptor board and valve 43 were replaced, but the issue remained.The system was powered down, and allowed to sit for a little while.After returning to run additional diagnostic tests, the issue was not able to be duplicated.The unit has been returned to service at the user facility without a recurrence of the event as reported.
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Search Alerts/Recalls
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