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
Thermal Decomposition of Device (1071); Melted (1385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 powered off unexpectedly during heat disinfect mode.A fresenius regional equipment specialist (res) inspected the machine, and confirmed there was visible burn damage on the mother board.The mother board was burned and melted where it connects to the heater rod.The burned board was noticed during machine repair.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 22,774 hours and the mother board was the original fresenius part on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and melted mother board.The mother board was discarded by the biomed and is not available to be returned to the manufacturer for physical evaluation.The biomed reportedly was waiting for a replacement mother board to complete the repair and return the machine to service.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius regional equipment specialist (res), who confirmed visible damage on the motherboard.The res noted something had been spilled on the motherboard near the display connection port, and noted there was a burn mark in the area.The res advised the clinic biomedical technician order and install a new motherboard to resolve the 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 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.
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Search Alerts/Recalls
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