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 USER FACILITY REPORTED TO A FRESENIUS CLINICAL CONSULTANT THAT BLOOD LEAKED FROM A CRACK FOUND IN A CLIC BLOOD CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS REPORTEDLY SPOTTED QUICKLY, AND THE ISSUE WAS RESOLVED WITHOUT INCIDENT TO THE PATIENT. THERE WERE NO REPORTS OF ANY SERIOUS PATIENT INJURY OR HARM, AND THERE WAS NO INDICATION THAT THE PATIENT REQUIRED MEDICAL INTERVENTION. PHOTOS OF THE CLIC BLOOD CHAMBER WERE PROVIDED FOR REVIEW. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.