OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY; 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
Itching Sensation (1943); Reaction (2414)
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Event Date 04/15/2020 |
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, it is likely the patient experienced a dialyzer reaction, characterized by itching.It is well-documented that patients on hemodialysis may experience hypersensitivity and allergic reactions due to the dialyzer membrane of various types of dialyzers.The fresenius optiflux 180nre dialyzer instructions for use cautions user of the known risk of hypersensitivity or anaphylactoid reactions to optiflux dialyzers during use.Currently, there is no objective evidence of a dialyzer product deficiency or malfunction associated with the event.
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Event Description
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It was reported that a hemodialysis (hd) patient experienced a reaction in the form of itching as a result of their hd treatment.Upon follow up with the facility administrator and hd registered nurse (hdrn), it was confirmed this patient had experienced an allergic reaction involving pruritis while undergoing hd therapy on (b)(6) 2020.The patient was able to complete hd therapy without any further reported issues and was treated with benadryl 25 mg orally.The patient did not develop any additional symptoms, injury, or adverse event as a result of the reported occurrence.It is unknown if the patient¿s itching subsided.There were no reports of anything unusual involving cleaning agents, consumable medical equipment or hemodialysis (hd) therapy.It was reported that the actual dialyzer sample was discarded however, a companion sample from the same lot is available to be returned to the manufacturer for evaluation.
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Manufacturer Narrative
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Additional information was received from the facility administrator clarifying that the correct item code is for the dialyzer is 0500318n.This information is consistent with the reported lot number 19nu04010.Clinical investigation update: based on the available information, it is likely the patient experienced a dialyzer reaction, characterized by itching.It is well-documented that patients on hemodialysis may experience hypersensitivity and allergic reactions due to the dialyzer membrane of various types of dialyzers.The fresenius optiflux 180nr dialyzer instructions for use cautions user of the known risk of hypersensitivity or anaphylactoid reactions to optiflux dialyzers during use.Currently, there is no objective evidence of a dialyzer product deficiency or malfunction associated with the event.
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Manufacturer Narrative
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Additional information: d10, h3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation and to date, no representative sample has been returned.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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