A user facility nurse reported that a patient complained of pruritis (itching) during hemodialysis (hd) therapy with the fresenius optiflux 180nre dialyzer, despite a full recirculation of normal saline (nacl) and one full liter of normal saline flushed through the dialyzer prior to the treatment.Follow-up medical treatment information was provided, which confirmed that the patient had complained of itching and was administered benadryl (diphenhydramine) 25mg intravenously (iv); however, the medication was reportedly not effective.The nurse stated that she will discuss the possibility to change the dialyzer with the patient¿s medical doctor.The treatment information also reported that the patient complained of cramps in which the ultrafiltration (uf) rate was minimized and the patient was administered 100 ml of nacl.The patient completed the scheduled hd treatment and was discharged to home in stable condition.No malfunction of the fresenius dialyzer in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event.The complaint device has not been returned to the manufacturer for evaluation.
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The information supports a temporal association between the optiflux dialyzer and the reported itching.However, there is no documentation to support a causal relationship between the itching and the optiflux dialyzer.The use of the optiflux dialyzer (polysulfone membrane, electron beam sterilization) was changed to the baxter exeltra 150 (cellulose triacetate membrane, gamma irradiation sterilization), and the itching had reoccurred.Also, the patient was administered heparin during hemodialysis (hd) treatment.It is unknown if there is a potential heparin allergy.A temporal association with the fresenius 2008k hd machine and cramping during hd treatment exists; however, this only led to temporary discomfort, the patient was given normal saline, and the ultrafiltration rate was turned off.There was no allegation of product malfunction.The patient was discharged to home in stable condition and returned for the next scheduled hd treatment.The patient has continued with hd therapy for renal replacement therapy.Plant investigation: the device was not returned to the manufacturer and the lot was not provided.A definitive conclusion regarding the complaint cannot be reached without physical examination of the complaint device.A records review was conducted on 14 lots of fresenius dialyzers (catalog 0500318e) identified to have been shipped to this account from 6/30/2016 to 5/1/2017.Three lots were identified with one approved temporary deviation notice per lot and one lot was identified with one material containment hold; the lot was subsequently released.There was no non-conformance, deviation, rework, or process control issues which could be associated with the reported event.The records review did not reveal a probable cause for the complaint.Additionally, the dialyzer instructions for use (ifu) is included in each case of fresenius dialyzer product and cautions the user regarding reactions.
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