Clinical investigation: the documentation in this complaint supports a temporal association between the optiflux 160nre dialyzer and the patient¿s complaints of shortness of breath and becoming anxious during hemodialysis (hd) treatment.However, it is documented in the clinical record that an allergy to the dialyzer remains unconfirmed.Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation and a lot number was not provided.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A search was performed of product lot numbers for the reported dialyzer catalog number (0500316e) that were shipped to the hospital facility for the three (3) month time frame which immediately preceded the event occurrence date.The search found no lots delivered to the facility within this time frame.The manufacturer performed an additional search in order to obtain the most recently received lot number for this facility and no results were yielded for any dialyzer product from the occurrence date to three years prior.As such, no product records could be reviewed.As a sample has not been provided for evaluation, a definitive conclusion regarding the complaint incident cannot be determined.Additionally, the dialyzer instructions for use (ifu) document is included in each case of fresenius optiflux dialyzer product and cautions the user regarding reactions.
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A user facility clinic manager reported that while a hemodialysis (hd) patient was hospitalized from (b)(6) 2017 through (b)(6) 2017 for shortness of breath and fluid overload, the patient received scheduled hd therapy on (b)(6) 2017 and experienced reactions with use of a fresenius optiflux 160nre dialyzer.The patient¿s treatment ended approximately one and a half hours early.The patient was reportedly unable to tolerate the hd treatment due to symptoms of anxiety and shortness of breath.The hospital originally attributed these symptoms to the patient¿s use of the medication bumex and the patient¿s condition of chronic obstructive pulmonary disease (copd).The patient¿s hd clinic informed the hospital that the patient had previously experienced the same symptoms during hd treatment at the clinic with use of the fresenius optiflux 160nre dialyzer, but the patient was changed to the baxter exeltra 150 dialyzer on (b)(6) 2017 prior to the patient¿s hospital admission, and hd treatment was better tolerated by the patient.Therefore, the hospital ordered that the patient¿s next hd treatment on (b)(6)2017 with the use of a baxter exeltra 150 dialyzer and the patient was able to complete the hd treatment without any complaints or symptoms.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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