CT-190G CELLULOSE TRIACETATE

Description of Event or Problem

INITIALLY, THE COMPLAINT ORIGINATED AS A RESULT OF THE BAXTER RENAL CLINICAL HELPLINE REPRESENTATIVE (BRCR) RECEIVING A VOICE MAIL MESSAGE FROM THE BAXTER SALES REPRESENTATIVE (BSR) ACCOUNT MANAGER ON (B)(4) 2010 REQUESTING CONTACT WITH THE NURSE MANAGER WHO HAD A CLINICAL QUESTION. ON (B)(4) 2010, PRODUCT SURVEILLANCE PLACED A FOLLOW UP CALL TO THE NURSE MANAGER REGARDING THE INCIDENCES AND THE RELATED COMPLAINTS. THE NURSE MANAGER STATED SHE SPOKE WITH THE BSR ON (B)(6) 2010, REGARDING THE HEMOLYSIS WITH THE TWO PATIENTS (B)(4) AND A THIRD INCIDENT (B)(4) WITH NO INJURY. THE NURSE MANAGER INDICATED THE 2ND PATIENT WAS USING A CT190G REUSE DIALYZER, EVENT DATE OF (B)(6) 2010. THE ACTUAL DIALYZER WAS DISCARDED. THE FACILITY EXPERIENCED DIFFICULTY ACCESSING THE PATIENT'S FISTULA. THE DIALYZER WAS FILLED TILL IT WAS PINK. ISSUES WERE NOTED WITH THE ARTERIAL LINE, ADJUSTMENTS WERE MADE AND THE PATIENT WAS CONNECTED TO BOTH THE ARTERIAL AND VENOUS LINES OF THE CATHETER. THERAPY WAS INITIATED AND IT WAS NOTED THE VENOUS PRESSURE WAS TOO LOW AT 60 AND 70 FOR THE ARTERIAL PRESSURE. THE DIALYZER WAS NOTED TO BE CLOTTING. THE FACILITY STAFF ATTEMPTED TO TROUBLE SHOOT THE ISSUE, BUT ULTIMATELY SET THE PATIENT UP ON A NEW MACHINE WITH NEW BLOODLINES AND DIALYZER. THE PATIENT COMPLETED THERAPY AND RETURNED HOME. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT (ED) AT 8:30 PM THAT NIGHT WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS SYSTEMATICALLY TREATED AND HOSPITALIZED FOR 4 DAYS. THE NURSE MANAGER STATED THE FACILITY USES A GAMBRO DEVICE, GAMBRO BLOODLINES AND MINNETECH RENALYN REUSE CHEMICAL. THIS IS THE SECOND PATIENT, PATIENT B, FOR DIALYZER ISSUES HOWEVER THIS PATIENT EXPERIENCED HEMOLYSIS.

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED.

Additional Manufacturer Narrative

(B)(4). THE MANUFACTURER, NIPRO, PERFORMED A BATCH REVIEW AND RETENTION SAMPLE REVIEW ON THE LOT NUMBER OF THE PRODUCT. NO ABNORMALITY WAS FOUND IN THE RECORDS OR FINDINGS OF THE BIOLOGICAL TESTS PERFORMED IN THE RELEASE INSPECTION OF THE LOTS INVOLVED. NO ABNORMALITY WAS FOUND IN THE FINDINGS OF THE BIOLOGICAL TESTS PERFORMED FOR THE RETAINED SAMPLES. A COMPANION SAMPLE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED AND NO OBVIOUS DEFECTS WERE FOUND. A BUBBLE POINT LEAK TEST WAS PERFORMED FOR ANY LEAKAGE AND THERE WERE NO BUBBLES PRESENT AND NO LEAKAGE COULD BE FOUND. A TREND REVIEW WAS PERFORMED AND NO ADVERSE TREND WAS ASSOCIATED WITH HEMOLYSIS AND NIPRO'S CELLULOSIC AND SYNTHETIC FIBERED DIALYZERS. ONLY 4 INCIDENTS WERE IDENTIFIED DURING THE TREND REVIEW. ALL FOUR INCIDENTS INCLUDED USING GAMBRO INSTRUMENTS AND BLOODLINES.

Description of Event or Problem

IT WAS REPORTED THAT THE PT'S INS RECHARGER WAS NOT CHARGING. THE PT STATED THAT THE BLACK AC POWER AC POWER CORD THAT WAS TO BE PLACED INTO THE RECHARGER DID NOT STAY PLUGGED IN. ADD'L INFO WAS RECEIVED THAT STATED THE PT DID NOT MEET WITH THE PHYSICIAN OR MFR REP REGARDING THE EVENT. IT WAS ALSO NOTED THAT THE PT HAD SURGERY ON (B)(6) 2010 AND IN (B)(6) 2010. NO DETAILS WERE PROVIDED FOR THESE EVENTS. IT WAS SUSPECTED THAT THERE WAS CONFUSION, AS THE DATE OF THE PT'S DEVICE IMPLANT WAS (B)(6) 2010. THE PT WAS SUCCESSFULLY REPROGRAMMED. THE PT WAS ALSO ABLE TO RECHARGE THE DEVICE SUCCESSFULLY AND WAS NO LONGER HAVING PROBLEMS WITH THE DEVICE SYSTEM. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT.