OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 0500318E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Swelling (2091); Reaction (2414)
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Event Date 09/14/2019 |
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: based on the available information, there is a likely causal relationship between the fresenius optiflux 180nr dialyzer and the patient¿s reaction (characterized by lip swelling and itching during the hd treatment).Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis.There is no evidence of an optiflux 180nr dialyzer product deficiency or malfunction.Additionally, although the patient experienced an adverse reaction during treatment, there is no allegation of a product malfunction or deficiency related to this event.
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Event Description
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It was reported during follow up to (b)(6) that the patient was utilizing the optiflux 180nr dialyzer and then experienced lip swelling and itching.The hemodialysis (hd) treatment was stopped, and the patient was administered benadryl (route and dose unknown).The patient did not require any additional intervention.The patient went on to try dialyzers from different manufacturers; however, continues to experience minor reactions.The patient is now being administered benadryl prior to treatment.It was not confirmed which dialyzer the patient is currently utilizing for treatments.
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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 were no other complaints reported against this lot, aside from the first incident of the current event experienced by the same patient.No other customers have reported any complaints, including an allergic reaction, when using this lot number.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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Search Alerts/Recalls
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