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
Charred (1086); Smoking (1585)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/09/2017 |
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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The user facility¿s biomedical technician reported that a fresenius 2008t hemodialysis (hd) machine was being troubleshot for a no chemical intake error message.The error message was generated during a chemical rinse cycle; therefore, no patient was involved.During the repair, a burning smell was noted, and a puff of smoke emanated from the unit.Further examination revealed that t5 of the power logic board was charred.The biomed replaced the power logic board and power control boards to resolve the issue.Additionally, the biomed replaced the filter screens in the wands, the acid and bicarb pumps, and the actuator board to resolve the no chemical intake error message.The machine has been returned to service at the user facility without a recurrence of the event as reported.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 provided by the biomed revealed that t5 of the power logic board was charred.The biomed replaced the power logic board and power control boards to resolve the issue.Additionally, the biomed replaced the filter screens in the wands, the acid and bicarb pumps, and the actuator board to resolve the no chemical intake error message.The 2008t hd machine 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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