SPECTRA OPTIA APHERESIS SYSTEM

Description of Event or Problem

ALMOST MIDWAY THROUGH THE PLASMA EXCHANGE IT WAS NOTICED THAT THE COLLECTION BAG WAS STILL EMPTY. PART OF THE BASE OF THE COLLECTION BAG WAS NOT SEALED. THE PLASMA WAS FLOWING OUT OF THE BAG, DOWN THE BACK OF THE MACHINE AND ON TO THE FLOOR. THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE WAS STOPPED. THE EXCHANGE WAS COMPLETED USING A SECOND APHERESIS MACHINE. REMAINING TPE KITS THAT WERE LEFT OF THAT LOT # WERE SEQUESTERED. THE AFFECTED KIT WAS SENT BACK TO THE MANUFACTURER. TPE MACHINE SERVICED BY MANUFACTURER, MACHINE WAS CLEANED AND VERIFIED NO SPILL INSIDE, ALL TESTS PASSED. MACHINE IN USE. CAUSE: MISSING RADIO-FREQUENCY (RF) BAR SEAL WELD ON THE BAG. SEE MFR REPORT IN THE DEVICE SECTION OF THIS REPORT. MANUFACTURER RESPONSE FOR THERAPEUTIC PLASMA EXCHANGE, SPECTRA OPTIA APHERESIS SYSTEM (PER SITE REPORTER). TERUMO BCT INC. REVIEWED THE RETURNED KIT. THEY SENT A LETTER WITH THE RESULT OF THEIR INVESTIGATION: "ROOT CAUSE: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, AND THE EVIDENCE FOUND IN THE EVALUATION OF THE RETURNED DISPOSABLE SET, THE CAUSE FOR THE REPORTED DEFECT WAS DUE TO A MANUFACTURING ERROR DURING THE RF WELDING PROCESS OF WELDING THE TUBING INTO THE WASTE BAG. THE STEP OF THE PROCESS WAS NOT PERFORMED AS WAS VISUALLY MISSED DURING INSPECTION." THE MISSING RF BAR SEAL WELD ON THE BAG CAUSED THE PLASMA TO LEAK OUT OF THE WASTE BAG.