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

A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED THIRTY MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. THE LEAK ORIGINATED FROM THE TWISTER CONNECTION. THERE WERE NO LOOSE CONNECTIONS OR ISSUES DURING PRIMING. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.