Patient was dialyzed using an a-22 dialyzer (lot number not documented by the center). Patient experienced hot flashes during the beginning of the dialysis treatment; normal saline was administered. (reportedly, patient has had similar experience with another manufacturer's dialyzer. ) treatment was continued without further incident. 3 days later patient was hospitalized for a duration of 10 days for what was reported as "conjunctivitis, subconjunctival hemorrhage, upper right arm paresis intense myaligia. Difficulty walking, and mild leukocytosis without hyperthermia. " patient was treated with ciprofloxacin iv, ophthalmologic gentalyn, ophthalmologic decadron, loratadine (route unknown), profenid (route unknown) and dexamethasone iv (doses and frequency are all unknown). Patient has reportedly recovered.

An urgent product recall of all althin dialyzers was conducted in 10/01. Communication was sent to hemodialysis physicians who received the a-series, which include the a-22 dialyzers, and af-series dialyzers, baxter documentation confirms that the reporting nephrologist received notification of this recall action. A rare reaction has been described in the literature in patients treated specifically with dialyzers containing cellulose acetate membranes. The primary clinical symptoms were ophthalmologic in nature and manifest themselves either during dialysis or the hours just following dialysis. Characteristic features of this reaction include conjunctivitis, iritis, scleritis, hearing loss, diminshed vision, arthralgia, myalgia, fever and headaches. Because of the hyperemia of the eye and subsequent red appearnce, the term "red eye syndrome" has been used to describe the condition. The reported described herein is identical to that described in the literature. The "red eye syndrome" has been reproduced in the past in laboratory studies on a variety of cellulose acetate dialyzers by the intravenous injection of cellulose acetate degradation products, specifically cellulose acetate oligomers (cao. ) the dialysis center was voluntarily closed by the center's nephrologist during which time the center conducted an investigation of the reverse osmosis (ro) water system. The center reported that the ro water treatment plant had been damaged and was being bypassed in dialysis treatments in 2003. Per the dialysis center, "all tests conducted were negative for contamination. " the water system was not tested for heavy metals. The water system membranes were changed and water test results are still pending. The clinic reopened as the ro water system was found to be operational. As lot number information was not available, the age and condition of the dialyzer in question in this report is unable to be determined. The center identified in this report, reported that the dialyzers were stored in a closed area without temperature control or monitoring mechanisms. A review of the distributor's delivery records indicates that it is likely the dialyzer used by the center was beyond the labeled three year expiration date. However, without samples or lot numbers this cannot be confirmed.