DISPOSABLE BLOOD TUBE SET

Description of Event or Problem

QUANTA WAS INFORMED ON (B)(6) 2023, THAT HEMODIALYSIS PATIENT ON (B)(6) 2023 SUFFERED A BLOOD LOSS WHILE ON DIALYSIS. IT WAS ESTIMATED THAT THE PATIENT LOST ABOUT 500MLS OF BLOOD. WHEN THIS WAS NOTICED THE PATIENT ADMINISTERED THEMSELVES A SALINE BOLUS TO INCREASE HIS BLOOD PRESSURE AND THEY STOPPED THE TREATMENT. THE PATIENT WAS NOT ADMITTED TO HOSPITAL FOLLOWING THE BLOOD LEAK BUT DID REPORT FEELING DIZZY INITIALLY AND FELT FINE AFTER SALINE BOLUS. DURING FOLLOW-UP, THE NURSE MENTIONED THAT THE CLAMP ON THE ANTICOAGULANT LINE WAS ENGAGED BUT IT DID NOT ALIGN CORRECTLY ON THE TUBING AND THEREFORE DIDN'T OCCLUDE THE LINE WHEN ENGAGED, AND NURSE CONFIRMED THAT THE CAP ON THE END OF THE ANTICOAGULANT LINE WAS LOOSE.

Additional Manufacturer Narrative

(B)(4). QUANTA ARE CURRENTLY INVESTIGATING THE REPORTED FAULT AND WILL PROVIDE INVESTIGATION RESULTS UPON CONCLUSION. QUANTA TECHNICAL TEAM WILL CONTINUE TO INVESTIGATE THAT THE DEVICE PERFORMED AS INTENDED. QUANTA CONTINUE TO WORK WITH THE CLINIC TO GAIN FURTHER INFORMATION ON CIRCUMSTANCES LEADING UP TO THE EVENT.