COMBISET ACCESS FLOW REVERSE CON TWISTER

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

IT WAS REPORTED THAT THIS PATIENT ON HEMODIALYSIS EXPERIENCED BLOOD LOSS (A FULL HEMODIALYSIS CIRCUIT; APPROXIMATELY 300 ML) REQUIRING HEMOGLOBIN MONITORING. IT WAS REPORTED THAT THE TWISTER APPARATUS ON THE FRESENIUS ACCESS FLOW COMBISET BLOOD LINES DISSECTED UPON ROTATION OF THE DEVICE. IN ADDITIONAL FOLLOW-UP VIA EMAIL AND A CALL WITH A HEMODIALYSIS NURSE. IT WAS DISCOVERED THAT WITH IN ONE HOUR OF THE TREATMENT, THE PATIENT WAS HAVING AN ACCESS FLOW TEST PERFORMED AND WHEN THE TWISTER APPARATUS ON THE FRESENIUS COMBISET WAS ROTATED THE DEVICE CRACKED. IT WAS CONFIRMED THAT THERE WERE NO INTERNAL BLOOD LEAKS AND NO ALLEGATIONS AGAINST THE FRESENIUS HEMODIALYSIS MACHINE OR DIALYZER. IT WAS STATED A VISIBLE CRACK WAS OBSERVED WITH VISIBLE BLOOD LEAK ON THE FRESENIUS COMBISET. AS A RESULT, THE PATIENT¿S TREATMENT WAS ENDED. THE PATIENT WAS NOT RETURNED THEIR BLOOD IN THE HEMODIALYSIS CIRCUIT. THE HEMODIALYSIS NURSE REPORTED THAT THERE WAS NO CHANGE IN THE PATIENT¿S BLOOD PRESSURE. THE PATIENT WAS RESET UP WITH NEW SUPPLIES AND RECEIVED 250ML OF SALINE FROM THE NEWLY PRIMES DIALYSIS CIRCUIT (STANDARD OF CARE). THE NURSE CONFIRMED THAT THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION FOR THE REPORTED BLOOD LOSS OF APPROXIMATELY 300ML. ADDITIONALLY, THE NURSE STATED THE PATIENT¿S HEMOGLOBIN WAS MONITORED AFTER THE EVENT AND THE FOLLOWING HEMODIALYSIS TREATMENT. HOWEVER, IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE ANY CHANGES IN HEMOGLOBIN OR REQUIRE MEDICAL INTERVENTION.