Model Number DD+CT17H |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Rash (2033); Reaction (2414)
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Event Date 09/22/2018 |
Event Type
Injury
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Event Description
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Clinic manager reported a patient who had dialyzer reactions on unspecified dates since (b)(6) 2018.Patient's first dialysis was (b)(6) 2018.No reactions were encountered between (b)(6) 2018 and (b)(6) 2018.Patient was using the optiflux 180nre.The clinic manager first thought the reaction was due to the gloves, gloves were changed and the patient continued to have allergic reaction.Dialyzer was then changed to the optiflux 180nr, but the patient continued to have allergic reaction.The clinic manager then changed to the nipro cellentia 17h on (b)(6) 2018, the patient reportedly had a few small hives and slight itching during mid-treatment to last hour of treatment.The clinic manager confirmed that the dialyzer was flushed with normal saline solution prior to treatment, priming flushing dialyzer with 2 liter nss every treatment per physician orders and confirmed that benadryl was administered to the patient intravenously both pre-treatment and mid-treatment.The clinic manager confirmed the patient completed their treatments, and confirmed the patient's symptoms resolve after treatment is completed.Lot numbers were not recorded.Patient continues to have reaction but is improved in severity to mild, patient no longer has break out of blistering hives while using the cellentia.There have been no known changes in any products used during dialysis.Usual dialysis medications are given (iv iron, engerix, calcitriol, heparin) current medications are heparin and prn meds (zofran, tylenol, dextrose).Patient has not had any changes in medications.Dialysis order: tue/thur/sat; 4hrs treatment, bfr 450, dfr autoflow, dialysate 2.0 k, 2.5 ca, 1.0mg, 100 dextrose, sodiu, 140(meq/l), bicarb setting: 36(meq/l).
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Event Description
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Clinic manager reported a patient who had dialyzer reactions on unspecified dates since (b)(6) 2018.Patient's first dialysis was (b)(6) 2018.No reactions were encountered between (b)(6) 2018.Patient was using the optiflux 180nre.The clinic manager first thought the reaction was due to the gloves, gloves were changed and the patient continued to have allergic reaction.Dialyzer was then changed to the optiflux 180nr, but the patient continued to have allergic reaction.The clinic manager then changed to the nipro cellentia 17h on (b)(6) 2018, the patient reportedly had a few small hives and slight itching during mid-treatment to last hour of treatment.The clinic manager confirmed that the dialyzer was flushed with normal saline solution prior to treatment, priming flushing dialyzer with 2 liter nss every treatment per physician orders and confirmed that benadryl was administered to the patient intravenously both pre-treatment and mid-treatment.The clinic manager confirmed the patient completed their treatments, and confirmed the patient's symptoms resolve after treatment is completed.Lot numbers were not recorded.Patient continues to have reaction but is improved in severity to mild, patient no longer has break out of blistering hives while using the cellentia.There have been no known changes in any pruducts used during dialysis.Usual dialysis medications are given (iv iron, engerix, calcitriol, heparin) current medications are heparin and prn meds (zofran, tylenol, dextrose).Patient has not had any changes in medications.Dialysis order: tue/thur/sat; 4hrs treatment, bfr 450, dfr autoflow, dialysate 2.0 k, 2.5 ca, 1.0mg, 100 dextrose, sodiu, 140(meq/l), bicarb setting: 36(meq/l),.
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Manufacturer Narrative
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Investigation report attached is on representative retained samples since the customer did not provide a lot number related to the event.
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Search Alerts/Recalls
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