OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 0500318E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
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Event Date 01/23/2023 |
Event Type
Injury
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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.Clinical investigation: a temporal relationship exists between hd therapy utilizing the optiflux 180nre dialyzer, and the serious adverse events of an allergic reaction (characterized by itching, hives, dyspnea), early termination of treatment and hospitalization.These events occurred during hd therapy, and therefore it is highly probable the patient¿s use of an optiflux 180nre dialyzer prompted the serious adverse events.During hd therapy, blood comes into direct contact with a variety of materials and sterilization methods.Therefore, it is reasonable to conclude some patients may incur a hypersensitivity/allergic reaction while using these products.Additionally, hypersensitivity reactions have been known to occur days, months, or even years after use with the same dialyzer model.There is no allegation(s) and/or objective evidence indicating a fresenius device(s) and/or product(s) malfunctioned or failed to meet manufacturer specifications.However, the optiflux 180nre dialyzer cannot be disassociated from the serious adverse events.Based on the temporal relationship, traditional signs and symptoms of an allergic reaction, and no optiflux 180nre available for manufacturer evaluation, the dialyzer cannot be excluded from having a possible causal and/or contributory role in the serious adverse events.
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Event Description
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A user facility biomedical technician (biomed) reported that a hemodialysis (hd) patient experienced an allergic reaction to the optiflux 180nre dialyzer.This was confirmed via follow-up with the patient¿s hd registered nurse (hdrn).The patient reportedly arrived for their regularly scheduled hd treatment in stable condition, and treatment was initiated.Twenty-four minutes into treatment the patient complained of itching, difficulty breathing (dyspnea), and broke out in hives (visible).The patient¿s hd treatment was discontinued, and they were intravenously (iv) given 50 mg of benadryl as well as 2 liters of oxygen.The patient¿s hives remained visible after the administration of benadryl; therefore, the patient was given iv solu-cortef 100 mg and was transported to a local hospital and admitted.Although the details of the hospitalization were unavailable, the hdrn reported the patient fully recovered prior to discharge on (b)(6) 2023.The patient returned for their regularly scheduled treatment on (b)(6) 2023 and was transitioned to a nipro 17h dialyzer.Additionally, the patient¿s pretreatment extracorporeal circuit priming (normal saline) volume was increased from 300 ml to 1000 ml.Despite these changes, the patient continued to experience itching (hives remain resolved) during hd therapy.As a result, the patient consumes benadryl 50 mg prior to each treatment, and has a standing order for oral or iv benadryl.The optiflux 180nre was discarded following the events on (b)(6) 2023 and is therefore unavailable for a manufacturer evaluation.
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Manufacturer Narrative
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Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
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Event Description
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A user facility biomedical technician (biomed) reported that a hemodialysis (hd) patient experienced an allergic reaction to the optiflux 180nre dialyzer.This was confirmed via follow-up with the patient¿s hd registered nurse (hdrn).The patient reportedly arrived for their regularly scheduled hd treatment in stable condition, and treatment was initiated.Twenty-four minutes into treatment the patient complained of itching, difficulty breathing (dyspnea), and broke out in hives (visible).The patient¿s hd treatment was discontinued, and they were intravenously (iv) given 50 mg of benadryl as well as 2 liters of oxygen.The patient¿s hives remained visible after the administration of benadryl; therefore, the patient was given iv solu-cortef 100 mg and was transported to a local hospital and admitted.Although the details of the hospitalization were unavailable, the hdrn reported the patient fully recovered prior to discharge on (b)(6) 2023.The patient returned for their regularly scheduled treatment on (b)(6) 2023 and was transitioned to a nipro 17h dialyzer.Additionally, the patient¿s pretreatment extracorporeal circuit priming (normal saline) volume was increased from 300 ml to 1000 ml.Despite these changes, the patient continued to experience itching (hives remain resolved) during hd therapy.As a result, the patient consumes benadryl 50 mg prior to each treatment, and has a standing order for oral or iv benadryl.The optiflux 180nre was discarded following the events on (b)(6) 2023 and is therefore unavailable for a manufacturer evaluation.
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