DISPOSABLE BLOOD TUBE SET

Additional Manufacturer Narrative

UDI: (B)(4). QUANTA IS CURRENTLY INVESTIGATING THE REPORTED FAULT AND WILL PROVIDE INVESTIGATION RESULTS UPON CONCLUSION. THE SAMPLE IS PRESENTLY IN TRANSIT ANDUPON RECEIPT WE WILL PROVIDE ADDITIONAL INFORMATION. QUANTA TECHNICAL TEAM WILL CONTINUE TO INVESTIGATE THE ROOT CAUSE OF THE REPORTED ISSUE. A CAPA HAS BEEN INITIATED TO IDENTIFY AND DEFINE ANY ADDITIONAL MITIGATIONS TO BE ADDED TO FURTHER MITIGATE THE RISKS ASSOCIATED WITH THIS ISSUE. THE SAMPLE IS PRESENTLY IN TRANSIT AND QUANTA WILL DO A THOROUGH PRODUCT INVESTIGATION.

Description of Event or Problem

A HOME HEMODIALYSIS PATIENT REPORTED THAT DURING THEIR HEMODIALYSIS TREATMENT ON (B)(6), 2023, THEY SUFFERED A BLOOD LOSS WHILE ON DIALYSIS. THE PATIENT ADVISED THAT BLOOD LEAK WAS COMING FROM THE TOP OF THE PERISTALTIC LOOP ON THE BLOOD TUBE SET. THE PATIENT WAS UNABLE TO COMPLETE TREATMENT. THE PATIENT ESTIMATED LOSING ROUGHLY 500ML OF BLOOD. THE PATIENT DID NOT SEEK MEDICAL INTERVENTION DURING INCIDENT; HOWEVER, THE PATIENT LATER COMMUNICATED WITH THEIR RENAL UNIT AND WILL CONTINUE TO DO TREATMENT IN-CENTER.