Description of Event or Problem · 1
MULTIPLE RED BLOOD CELL (RBC) PUMP ALARMS DURING CELLEX EXTRACORPOREAL PHOTOPHERESIS (ECP) PROCEDURES THAT THE STAFF HAD BEEN EXPERIENCING FROM THE END OF 2013 THROUGH THE FIRST QUARTER OF 2014. THESE ALARMS OCCURRED ON BOTH CELLEX INSTRUMENTS AND WITH DIFFERENT CELLEX KIT LOT NUMBERS. THERE WERE 17 EVENTS WITH 8 PATIENTS DURING THIS TIME PERIOD. UNFORTUNATELY, OUR FACILITY¿S BLOOD TRANSFUSION SERVICE (BTS) NURSING STAFF WAS NOT ABLE TO PROCESS 1500ML OF WHOLE BLOOD (WB) AS RECOMMENDED BY THERAKOS. FORTUNATELY, BTS NURSING WAS ABLE TO PROVIDE THE PATIENTS WITH A COMPLETED PHOTO-ACTIVATED PROCEDURE. THESE TREATMENTS WERE OF LESSER WB VOLUMES PROCESSED (550ML TO 800ML) THAN THE WB VOLUME THAT THE PHYSICIAN PRESCRIBED (1500ML), BUT STILL ARE CONSIDERED EFFECTIVE AS A TREATMENT. WE AGAIN NOTIFIED THERAKOS OF CONTINUING / INCREASING CHALLENGES WITH THE RBC ALARMS OCCURRING ON ALL ECP PROCEDURES. BTS INFORMED THERAKOS THAT BTS HAD STOPPED USING THE OLDER KIT INVENTORY THINKING THAT IT WOULD RESOLVE THE PROBLEM, BUT IT DID NOT. AT THIS POINT BTS HAD BEGUN USING CELLEX KIT NUMBER B335 WHICH DID NOT RESULT IN IMPROVEMENT. REPLACEMENT CELLEX KITS WERE REQUESTED, WITH A DIFFERENT LOT NUMBER. THERAKOS HAS NOT REIMBURSED BTS FOR ANY KITS. ALTHOUGH THE TREATMENTS WERE EFFECTIVE, THE WB VOLUMES PROCESSED WERE SMALLER THAN USUAL. OUR BEST DETERMINATION IS THAT NO ACTUAL OR POTENTIAL HARM WAS DONE TO THE PATIENT AS A RESULT OF THE EQUIPMENT FAILURE TO OPERATE AS EXPECTED. BTS OPINION IS THAT THE APHERESIS KITS THAT ARE CURRENTLY BEING PRODUCED HAVE SOME SORT OF A DESIGN FLAW/FAILURE WHICH IS CAUSING THE PROBLEM. KIT LOTS AFFECTED ARE: A311, B324, B340, B335, B327, B338, B348 AND C305.MANUFACTURER RESPONSE FOR PHOTOPHORESIS INSTRUMENT, THERAKOS CELLEX (PER SITE REPORTER):ACCORDING TO THERAKOS, THIS PROBLEM HAD BEEN OCCURRING NATIONWIDE AND HAD BEEN REPORTED TO THERAKOS. THERAKOS STATED THAT THE ALARMS WERE NOT RELATED TO A PARTICULAR CELLEX KIT LOT NUMBER. THEY ALSO INFORMED BTS THAT THEY HAD RECEIVED FDA APPROVAL FOR A CELLEX BOWL DESIGN IMPROVEMENT. "UBER NUBBINS" WILL BE ADDED TO THE BASE OF THE BOWL WHICH WILL HOPEFULLY PREVENT BLOCKAGES FROM FORMING WITHIN THE BOWL THUS IMPROVING BLOOD FLOW AND ELIMINATING RBC PUMP ALARMS. A WORKAROUND FOR THIS PROBLEM WAS ALSO DISCUSSED. BTS WAS INSTRUCTED TO FOLLOW THE DIRECTIONS IN MANUFACTURER TECHNICAL BULLETIN #4 WHEN THE RBC PUMP ALARMS OCCUR AND IF UNSUCCESSFUL, CONTACT CUSTOMER SERVICE, WHICH HAS BEEN DONE - 9 TIMES. THERAKOS VISITED WITH US TO DISCUSS THE DAY TO DAY CHALLENGES OF ADMINISTERING ECP TREATMENTS. THEY INFORMED BTS THAT THERAKOS HAS OBSERVED INCREASING OCCURRENCES OF ALARM #45 (RBC PUMP ALARM) COMPLAINTS. THIS PROBLEM IS NOT UNIQUE AND HAS BEEN SEEN ACROSS SEVERAL CENTERS. IT IS NOT A KIT LOT SPECIFIC ISSUE; HOWEVER, THE KITS HAVE BEEN INVESTIGATED (INCLUDING A THIRD PARTY) FOR MEETING MANUFACTURING SPECIFICATIONS AND THEY HAVE ALL PASSED. THE RBC PUMP ALARM SYSTEM PRESSURE ALARM (#18) HAS BEEN THE HIGHEST COMPLAINT CATEGORY SINCE THE LAUNCH OF CELLEX. IT DOES NOT CREATE A HEALTH AND SAFETY ISSUE. THIS HAS BEEN OBSERVED FOR TWO YEARS. THE COMPANY PUT OUT A TECHNICAL BULLETIN (#4) TO AID IN WORKING THROUGH THE ALARM AND PROVIDING SUCCESSFUL TREATMENT. THERAKOS HAS BEGUN ACTIONS TO CHANGE THE DESIGN OF THE KIT TO REDUCE THE OCCURRENCE OF THESE ALARMS. THE DESIGN CHANGE IS IN VALIDATION. ACCORDING TO THERAKOS - THE FDA SHOULD ALLOW THEM TO PROCEED WITH THE DESIGN CHANGE AND HAVE THE KITS AVAILABLE FOR Q2 2014. THERE ARE ALSO ONGOING PROJECTS BY THERAKOS AND THE KIT MANUFACTURER (HARMAC MEDICAL LTD), TO ACHIEVE GREATER MANUFACTURING PROCESS CONTROLS AND INCREASED MANUFACTURING CAPABILITIES. THE VP OF RESEARCH AND DEVELOPMENT WILL BE COMING IN THE NEAR FUTURE TO SHARE MORE DETAIL.