CT-190G CELLULOSE TRIACETATE

Description of Event or Problem

A FACILITY ADMINISTRATOR CONTACTED BAXTER TO REPORT A SECOND DIALYZER REACTION DURING USE OF CT 190G DIALYZER. PATIENT WAS A MALE WHO WAS RECEIVING DIALYSIS TREATMENT, AND 4 MINUTES IN TO THE TREATMENT, DEVELOPED ACUTE SHORTNESS OF BREATH, CHEST PAIN AND BACK PAIN. THE TREATMENT WAS DISCONTINUED AND THE EXTRACORPOREAL BLOOD RECIRCULATED. THE PHYSICIAN WAS NOTIFIED THAT THE DIALYZER USED THIS DAY WAS PRE- PROCESSED, NUMBER OF REUSES 0. THE DOCTOR ORDERED SOLUMEDROL 40MG IV PUSH, SWITCH TO A NEW DIALYZER, GAMBRO24, PERMANENTLY AND RINSED WITH 2.0L NORMAL SALINE SOLUTION PRIOR TO USE. THE SYMPTOMS SIGNIFICANTLY IMPROVED AND THE PATIENT WAS ABLE TO COMPLETE THE TREATMENT WITHOUT FURTHER CLINICAL CONSEQUENCES. ADDITIONAL INFORMATION OBTAINED DURING A CUSTOMER VISIT. THIS PATIENT HAS A HISTORY OF ALLERGIC REACTION DUE TO CELLULOSE DIALYZER MEMBRANE.

Additional Manufacturer Narrative

BAXTER INITIATED AND INVESTIGATION UPON RECEIVING THIS REPORT. THE ACTUAL AND COMPANION SAMPLES HAVE BEEN REQUESTED FOR EVALUATION. BAXTER RECEIVED ONE USED DIALYZER FOR THIS COMPLAINT/ENTRY. AN ATTEMPT WAS MADE TO DISINFECT THE SAMPLE USING BLEACH SOLUTION METHOD DEFINED IN RD-RQ-C-005. THE SAMPLE WAS STILL BIOHAZARDOUS AFTER DISINFECTION (BLOOD WAS VISIBLE WITHIN DIALYZER). IT WAS OBSERVED THAT THE SAMPLE HAD SEVERE FIBER DAMAGE THAT ALLOWED DISINFECTANT FROM THE BLOOD CIRCUIT TO FLOW INTO DIALYSATE COMPARTMENT. FURTHER ANALYSIS CANNOT BE PERFORMED ON THIS UNIT DUE TO BIOHAZARDOUS CONDITION OF THIS SAMPLE. THE INVESTIGATION IS STILL PENDING. IF ADDITIONAL INFORMATION IS DISCOVERED A FOLLOW UP REPORT WIL BE SUBMITTED.