Catalog Number 190766 |
Device Problem
Fire (1245)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/18/2017 |
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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A biomedical technician at a user facility reported to technical support that a 2008t hemodialysis (hd) machine had valve 103 caught fire during bleach disinfect.No patient was connected to the machine at the time of the incident.Therefore, no patient was involved.Follow-up confirmed the use of hospital grade ground fault circuit interrupter (gfci) outlets at the user facility.The biomedical technician replaced the bibag hydraulics assembly to resolve the issue.Following the parts replacement, the system was restored to full functionality.Functional testing performed by the biomedical technician confirmed the system was operating properly.The unit has been returned to service at the user facility without a recurrence of the event as reported.No parts were 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.The biomedical technician indicated that the bibag hydraulics assembly was replaced which resolved the issue.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 deviations or non-conformances 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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Search Alerts/Recalls
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