CONCORD MANUFACTURING T; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 190713 |
Device Problems
Thermal Decomposition of Device (1071); Fire (1245)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/23/2017 |
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 fire in the card cage that damaged the actuator/test board, function board, usb1 cable p/n 190717, rs-232 cable and the actuator cable.The biomed tech stated he was troubleshooting a low flow error message when he smelled a burning smell from the card cage for about one minute.No audible alarms were noted or expected because the dialysate lines were on the shunt.The machine continued running and he completed a heat disinfect before turning it off.The next morning the staff turned the machine on and it gave a failed sending data to actuator board message.The card cage was opened to troubleshoot and the biomed tech reported signs of the fire.There was damage to the boards and cables and black soot indicating that there had been a fire.No flames or smoke were noted, and only a short burning smell was reported.Additional follow-up with the biomed tech revealed diode 19 and the driver ic below it were burnt on the actuator board.The biomed tech reported he had performed a pm on this machine and rebuilt the deaeration motor, and the incident occurred after the biomed tech installed the motor and ran the machine.Components were available to be returned for evaluation.
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Manufacturer Narrative
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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 fire in the card cage that damaged the actuator/test board, function board, usb1 cable p/n 190717, rs-232 cable and the actuator cable.The biomed tech stated he was troubleshooting a low flow error message when he smelled a burning smell from the card cage for about one minute.No audible alarms were noted or expected because the dialysate lines were on the shunt.The machine continued running and he completed a heat disinfect before turning it off.The next morning the staff turned the machine on and it gave a failed sending data to actuator board message.The card cage was opened to troubleshoot and the biomed tech reported signs of the fire.There was damage to the boards and cables and black soot indicating that there had been a fire.No flames or smoke were noted, and only a short burning smell was reported.Additional follow-up with the biomed tech revealed diode 19 and the driver ic below it were burnt on the actuator board.The biomed tech reported he had performed a pm on this machine and rebuilt the deaeration motor, and the incident occurred after the biomed tech installed the motor and ran the machine.Components were available to be returned for evaluation.
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