CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 190713 |
Device Problem
Temperature Problem (3022)
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Patient Problem
High Blood Pressure/ Hypertension (1908)
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Event Date 06/14/2018 |
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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While servicing a fresenius 2008t hemodialysis (hd) machine at a user facility on (b)(6) 2018, a regional equipment specialist (res) technician reported a machine showing high temperatures in on line clearance test mode during treatment.The res technician reported that the issue could not be duplicated when he serviced the machine, and confirmed the machine passed all functional tests and returned to service.The res technician reported that at the time the high temperature issue occurred, the patient on the machine became hypertensive and was taken off the machine.
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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 reported that the issue could not be duplicated, and confirmed that the machine passed all functional tests and returned to service.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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