CLIC BLOOD CHAMBER

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A NURSE REPORTED THAT THERE WAS BLOOD LEAKING FROM THE DIALYSIS CIRCUIT, WHICH COULD RESULT IN AN INFECTION AND OTHER PATIENT SAFETY RISKS.THE NURSE SAID RECENTLY THERE WAS CIRCUIT LINES LEAKING BLOOD DURING A TREATMENT. TREATMENT WAS PAUSED AFTER THE LEAK. THE CONNECTIONS WERE TIGHTENED AND TREATMENT RESUMED. NEW LINES WERE NOT RESTRUNG. THE PATIENT DID RECEIVE PROPHYLACTIC ANTIBIOTICS.THE SAMPLE LINES ARE AVAILABLE TO RETURN. ATTEMPTS WERE MADE TO GATHER MORE DETAILS BUT NO INFORMATION WAS PROVIDED.