CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 190713 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.¿.
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Event Description
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A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had an acid pump that shorted and caused burn damage to the actuator board.The actuator board visually appeared burned and a burning smell was also observed.The acid pump and the actuator board were found during semi-annual preventative maintenance (pm) of the machine.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.The machine has approximately 29,000 hours and the acid pump and actuator board were the original fresenius parts on the machine.It was not reported by the biomed that there was any damage observed on any other components, or any other additional issues, associated with the acid pump and actuator board.The biomed replaced the acid pump and actuator board, which resolved the issue.The unit was returned to service at the user facility.The acid pump and actuator board were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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.
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Search Alerts/Recalls
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