COMBISET

Description of Event or Problem

OR ¿ COMBI SET BLOOD TUBING, LOT # 25PRO1123 I AM SUBMITTING THIS LETTER TO FORMALLY DOCUMENT A . CULTURE PATIENT SAFETY REPORT (JPSR), REFERENCE 32970, REGARDING POTENTIAL PATIENT HARM ASSOCIATED WITH THE USE OF COMBI SET BLOOD TUBING, LOT # 25PRO1123. THE PURPOSE OF THIS REPORT IS TO DESCRIBE THE EVENT, OUTLINE THE POTENTIAL RISKS TO PATIENTS, AND REQUEST REVIEW AND FOLLOW UP ACTIONS BY THE APPROPRIATE LEADERSHIP AND SAFETY TEAMS. SITUATION DURING PRE TREATMENT SAFETY CHECKS, A CRACK WAS OBSERVED ON THE ARTERIAL SIDE OF THE COMBI SET BLOOD TUBING, JUST BELOW THE MEDICATION PORT. THIS DEFECT HAS BEEN OBSERVED ON A TOTAL OF FIVE DIFFERENT BLOOD LINE SETS FROM THE SAME LOT AND HAS BEEN IDENTIFIED BY MORE THAN ONE STAFF MEMBER. THESE CRACKS WERE IDENTIFIED PRIOR TO INITIATING PATIENT TREATMENT, AND THE AFFECTED TUBING SETS WERE REMOVED FROM USE AND REPLACED IN ACCORDANCE WITH UNIT PROTOCOL. ALTHOUGH THE CRACKS WERE NOTED BEFORE TREATMENT BEGAN, THERE IS CONCERN THAT A MICRO LEAK AT OR NEAR THIS SITE MAY HAVE CONTRIBUTED TO A DECREASED FLUID LEVEL IN THE ARTERIAL CHAMBER DURING SETUP ON AT LEAST ONE OCCASION. STANDARD TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING VERIFICATION OF ALL CONNECTIONS, PRIMING AND FILL VOLUMES, MACHINE SETTINGS, AND PATIENT PARAMETERS, BUT NO CLEAR ALTERNATIVE CAUSE FOR THE DECREASED ARTERIAL CHAMBER VOLUME COULD BE IDENTIFIED. THIS RAISES CONCERN THAT SIMILAR, LESS VISIBLE DEFECTS IN THIS LOT COULD LEAD TO UNDETECTED BLOOD OR FLUID LOSS, AIR ENTRY, OR INTERRUPTION OF THERAPY IF NOT IDENTIFIED PRIOR TO OR DURING TREATMENT. CRACKS OR LEAKS IN ARTERIAL BLOOD LINES ARE KNOWN TO CREATE RISKS OF BLOOD LOSS, TREATMENT INTERRUPTION, AND INFECTION IF THEY OCCUR DURING HEMODIALYSIS. POTENTIAL PATIENT IMPACT BASED ON THE OBSERVED DEFECT AND CLINICAL CIRCUMSTANCES, THERE IS A POTENTIAL FOR: BLOOD LOSS AND HEMODYNAMIC INSTABILITY IF LEAKAGE OCCURS DURING TREATMENT. INTRODUCTION OF AIR INTO THE EXTRACORPOREAL CIRCUIT WITH RISK OF AIR EMBOLISM, PARTICULARLY IF LEAKAGE OCCURS BEYOND MONITORING POINTS. CONTAMINATION OF THE EXTRACORPOREAL CIRCUIT WITH ASSOCIATED RISK OF BLOODSTREAM INFECTION IN DIALYSIS PATIENTS, WHO ARE ALREADY AT INCREASED INFECTION RISK. INCOMPLETE OR INTERRUPTED TREATMENT LEADING TO SUBOPTIMAL DIALYSIS DELIVERY. TO DATE, NO DIRECT PATIENT HARM HAS BEEN CONFIRMED FROM THESE SPECIFIC CRACKED LINES, AS THE DEFECTS WERE IDENTIFIED BEFORE TREATMENT. HOWEVER, THE REPEAT OCCURRENCE ACROSS MULTIPLE BLOOD LINE SETS FROM LOT # 25PRO1123 REPRESENTS A PRODUCT RELATED SAFETY CONCERN THAT WARRANTS PROMPT INVESTIGATION AND CORRECTIVE ACTION. ACTIONS TAKEN THE TUBING SETS FROM LOT # 25PRO1123 INVOLVED IN THESE OBSERVATIONS HAVE BEEN REMOVED FROM SERVICE. LOCAL MANAGEMENT AND LMS HAVE BEEN NOTIFIED, AND ONE REPRESENTATIVE AFFECTED LINE HAS BEEN RETAINED AS A SAMPLE FOR VENDOR AND QUALITY REVIEW, IN LINE WITH EXISTING GUIDANCE TO RETAIN DEFECTIVE ARTERIAL BLOOD LINES FOR INVESTIGATION. THE ASSOCIATED JPSR (REFERENCE 32970) HAS BEEN COMPLETED IN OUR FACILITY EVENT REPORTING SYSTEM. HEALTH EFFECT CODE: 4582, DEVICE PROBLEM CODE: 1135, 1250. REF:  MW5189643, MW5189644, MW5189645, MW5189647. THIS REPORT CAPTURES "COMBISET #4".