RENALIN 100

Description of Event or Problem

FACILITY REPORTS POSSIBLE RENALIN REACTION WITH ONE PT. PT WAS HOSPITALIZED.

Additional Manufacturer Narrative

EVAL WAS INTERVIEWING NURSE MGR IN 2008, WHO REPORTED 3 MINS INTO TREATMENT, THE PT COMPLAINED OF SHORTNESS OF BREATH, CHEST PAIN, WAS DIAPHORETIC AND HAD A FEELING OF IMPENDING DOOM. TREATMENT WAS STOPPED AND THE DIALYZER WAS CHECKED TO MAKE SURE IT WAS THE PT'S OWN DIALYZER (IT WAS). DUE TO THE PT FEELING SO BAD, THEY DID NOT RE-INITIATE DIALYSIS ON A "DRY PACK" BUT SENT THE PT DIRECTLY TO THE HOSP WHERE HE WAS ADMITTED. (PT WAS HOSPITALIZED SIX DAYS PRIOR, AND RELEASED THREE DAYS LATER). NO OTHER INFO IS AVAILABLE AT THIS TIME AS TO WHAT TYPE OF TREATMENT PT RECEIVED WHILE IN THE HOSP. PT WAS BEING DIALYZED WITH AN ASAHI REXEED 18R DIALYZER THAT HAD BEEN REPROCESSED 12 TIMES. NURSE MGR STATED THE BLOOD PATHWAY WAS CHECKED FOR RENALIN RESIDUALS USING RENALIN RESIDUAL TEST STRIPS BEFORE THE PT WAS CONNECTED TO MACHINE. THE RESULTS WERE NEGATIVE. AFTER THE PT HAD THE REACTION, A BIOMED TECH CHECKED THE DIALYSATE SIDE FOR RENALIN RESIDUALS. THE RESULTS WERE POSITIVE. MFR DOES NOT RECOMMEND CHECKING FOR RESIDUALS AT THE DIALYSATE PORTS BECAUSE A "CLEAN CATCH" CANNOT BE ASSURED. HANSON CONNECTORS CAN HOLD RESIDUAL RENALIN IN THEM WHICH WOULD GIVE THE STRIP A "FALSE POSITIVE" RESULT FOR THE DIALYZER. NURSE MGR STATED THE PT IS DOING FINE WITH NO ILL AFTER EFFECTS FROM THIS INCIDENT.