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 REGISTERED NURSE (RN) REPORTED THAT A COMBISET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE RN NOTICED BLOOD LEAKING FROM THE HEPARIN LINE APPROXIMATELY FIFTEEN MINUTES INTO THE TREATMENT. THEY SUSPECTED THAT THE CAP ON THE END OF THE HEPARIN LINE WAS NOT SECURE BECAUSE IT POPPED OFF ONCE PRESSURE STARTED TO BUILD UP WITHIN THE CIRCUIT. THE HEPARIN LINE ALSO WAS NOT CLAMPED, AND AS A RESULT, BLOOD LEAKED OUT OF THE LINE WHEN THE CAP CAME OFF. THERE WERE NO ALARMS FROM THE MACHINE, A FRESENIUS 2008T. THE RN WAS ABLE TO STOP THE LEAK BY CLAMPING THE LINE, AND THE PATIENT¿S TREATMENT WAS CONTINUED USING THE SAME SUPPLIES. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THE RN CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR FULL TREATMENT ON THE MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.