OPTIFLUX F160NRE HF 12/CS 1.5SA EBEAM

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: PRESENTLY THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A SERIOUS INJURY, PATIENT DEATH, OR OTHER ADVERSE EVENT(S) REQUIRING MEDICAL INTERVENTION THAT OCCURRED RELATED TO A FRESENIUS PRODUCT(S) OR DEVICE(S).

Description of Event or Problem

A HEMODIALYSIS (HD) REGISTERED NURSE [(HD)RN] REPORTED, THIS HD PATIENT ON IN-CENTER HD THERAPY UTILIZING THE OPTIFLUX F160NRE DIALYZER EXPERIENCED A BLOOD LEAK RESULTING IN 300 ML BLOOD LOSS, NAUSEA AND VERTIGO. THERE WAS NO SPECIFIC ALLEGATION THAT THIS EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. UPON REVIEW OF THE INFORMATION PROVIDED IN THE FOLLOW-UP, IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK OCCURRED ON (B)(6) 2026 DURING THIS PATIENT¿S HD TREATMENT APPROXIMATELY THREE TO FIVE MINUTES AFTER INITIATION. THE PATIENT WAS IMMEDIATELY CLAMPED, DISCONNECTED, AND NO BLOOD WAS RETURNED. THE PATIENT¿S TOTAL ESTIMATED BLOOD LOSS WAS 300 ML. THERE WAS NO INDICATION THAT MEDICAL INTERVENTION WAS PROVIDED TO ADDRESS THE BLOOD LOSS AND THE PATIENT WAS PLACED ON AN ADDITIONAL TREATMENT. APPROXIMATELY 20 MINUTES FOLLOWING INITIATION OF THE SECOND TREATMENT, THE PATIENT BEGAN TO EXPERIENCE DIZZINESS AND NAUSEA. EMERGENCY MEDICAL SERVICES WERE ACTIVATED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR FURTHER EVALUATION. NO DETAILS WERE PROVIDED CONCERNING THE PATIENT¿S HOSPITAL VISIT AND ANY DIAGNOSIS(ES), TREATMENT DETAILS AND THE PATIENT¿S CURRENT DISPOSITION REMAIN UNKNOWN. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE FURTHER DETAILS CONCERNING THIS PATIENT¿S ADVERSE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED.