Model Number ELISIO 21H |
Device Problem
Biocompatibility (2886)
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Patient Problems
Itching Sensation (1943); Reaction (2414)
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Event Date 09/13/2018 |
Event Type
Injury
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Event Description
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Patient had an allergic reaction 2hours and 20 minutes after treatment was initiated.Patient experienced itchy sking and swelling of the tongue and lips.Treatment was stopped.Steroid and adrenal injection was administered, patient has been under the care of a cardiologist.Dialysis conditions: treatment time: 4hours, blood flow rate: 300, dialysate flow rate: 500, heparin volume: fraxiparine 0.2.Dialysis machine used: fresenius 5008, bloodline: av-set online plus bvm 5008-r (f00000385), medtronic catheter: (model unknown).
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Manufacturer Narrative
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Investigation report attached on retained samples only.On 10/26/2018: investigation report attached on retained samples, final investigation report on returned sample is still in progress.(b)(4).
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Event Description
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Patient had an allergic reaction 2hours and 20 minutes after treatment was initiated.Patient experienced itchy sking and swelling of the tongue and lips.Treatment was stopped.Steroid and adrenal injection was administered, patient has been under the care of a cardiologist.Dialysis conditions: treatment time: 4hours, blood flow rate: 300, dialysate flow rate: 500, heparin volume: fraxiparine 0.2 dialysis machine used: fresenius 5008, bloodline: av-set online plus bvm 5008-r (f00000385), medtronic catheter: (model unknown).
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Manufacturer Narrative
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Investigation report attached on retained samples only.(b)(6)2018 : investigation report attached on retained samples, final investigation report on returned sample is still in progress.(b)(6)2018 : date of device(actual used) returned to manufacturer is unknown, final investigation report attached is on actual used device.
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Event Description
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Patient had an allergic reaction 2hours and 20 minutes after treatment was initiated.Patient experienced itchy sking and swelling of the tongue and lips.Treatment was stopped.Steroid and adrenal injection was administered, patient has been under the care of a cardiologist.Dialysis conditions: treatment time: 4hours, blood flow rate: 300, dialysate flow rate: 500, heparin volume: fraxiparine 0.2 dialysis machine used: fresenius 5008, bloodline: av-set online plus bvm 5008-r (f00000385) medtronic catheter: (model unknown.).
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Search Alerts/Recalls
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