DISPOSABLE BLOOD TUBE SET (HLS)

Additional Manufacturer Narrative

(B)(4). THIS IS AN INITIAL AND FINAL REPORT. SIMILAR REPORT HAS BEEN SUBMITTED TO MHRA. FOLLOWING INVESTIGATION ACTIVITIES WERE CONDUCTED BY QUANTA: MACHINE DIAGNOSTICS: QUANTA REVIEWED INTERNAL MACHINE DIAGNOSTIC DATA TO IDENTIFY ANY POTENTIAL INDICATORS OF ABNORMAL PERFORMANCE OF THE SC+ HEMODIALYSIS SYSTEM. NO INDICATIONS OF ANY POTENTIAL ISSUES THAT COULD LEAD TO BLOOD LEAK WERE IDENTIFIED THROUGH THE REVIEW OF THE MACHINE DIAGNOSTICS DATA. RETURN PRODUCT EVALUATION: QUANTA RECEIVED THE MACHINE AND CONSUMABLES ASSOCIATED WITH THIS COMPLAINT ON (B)(6) 2023, FOR FURTHER INVESTIGATION. THE MACHINE WAS INVESTIGATED AND IT WAS CONCLUDED THAT THE MACHINE WAS FULLY FUNCTIONAL AND WITHIN SPECIFICATION. THE RETURNED CONSUMABLE WAS INVESTIGATED AND TESTED TO DETERMINE WHETHER THERE WAS A BREACH IN THE CIRCUIT THAT MAY HAVE CAUSED THE REPORTED BLOOD LEAK. TESTING CONCLUDED THAT THE INTEGRITY OF THE BTS WAS NOT COMPROMISED AND THERE WAS NO LEAK PATH. REVIEW OF FAILURE IMAGE FROM CUSTOMER: FURTHER FOLLOW UP WITH THE CUSTOMER TO RECEIVE IMAGES OF THE LEAK SUGGESTED THAT THE LEAK OCCURRED AT THE ANTICOAGULANT LINE. BLOOD WAS OBSERVED THROUGH THE TUBE BEYOND THE CLAMP ON THE ANTICOAGULATION LINE. THIS COULD POTENTIALLY OCCUR IF THE CLAMP IS NOT PROPERLY CLOSED AND THE LUER CAP IS REMOVED OR NOT FULLY TIGHTENED. SINCE THERE IS NO BREACH IN THE BLOOD TUBE SET IT IS LIKELY THAT THIS EVENT IS THE RESULT OF USE ERROR. HUMAN FACTORS RISK REVIEW WAS PERFORMED AND THIS WAS IDENTIFIED AS A KNOWN RISK. THE USER MANUAL DIRECTS THE OPERATOR TO TIGHTEN THE ANTICOAGULANT LINE CAP AND CLOSE THE ANTICOAGULANT CLAMP AFTER PRIMING THE CIRCUIT. IN ADDITION TO THIS IT PROVIDES THE WARNING THAT LOOSE OR INCORRECTLY CONNECTED BLOOD LINES MAY RESULT IN BLOOD LEAKS AND THAT ALL CONNECTIONS SHOULD BE CHECKED TO ENSURE THAT THEY ARE TIGHT AND SECURE. HUMAN FACTORS RISK REVIEW WAS PERFORMED AND THIS WAS IDENTIFIED IN THE RISK FILES AND APPROPRIATE MITIGATIONS ARE IN PLACE TO REDUCE THE RISK AS FAR AS POSSIBLE. BASED ON THE RISK REVIEW AND INVESTIGATION, THIS WAS IDENTIFIED AS BEING AN ISOLATED EVENT RESULTING FROM A MISSING/LOOSE CAP AND UNCLAMPED ANTICOAGULATION LINE DURING TREATMENT AND IS MOST LIKELY TO BE THE RESULT OF USE ERROR. QUANTA WILL CONTINUE TO MONITOR REPORTED EVENTS THROUGH THEIR ROUTINE POST MARKET SURVEILLANCE ACTIVITIES.

Description of Event or Problem

QUANTA WAS INFORMED ON (B)(6) 2023 THAT A HEMODIALYSIS PATIENT ON (B)(6) 2023 SUFFERED A BLOOD LOSS WHILE ON DIALYSIS. ACCORDING TO THE PATIENT'S SPOUSE, A LEAK WAS OBSERVED UNDER THE MACHINE AND DOWN THE SIDE OF THE TROLLEY (CART). PATIENT BECAME DIZZY AND FELT UNWELL AND WAS TAKEN TO THE HOSPITAL. THE PATIENT WAS TREATED AND BECAME STABLE AND RELEASED SAME DAY. THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2023 TO HAVE BLOOD TRANSFUSION AND TO RESUME DIALYSIS TREATMENT.