COMBISET BLOODLINE

Additional Manufacturer Narrative

PLANT INVESTIGATION: 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 PATIENT CARE TECHNICIAN (PCT) BLOOD LEAK DETECTOR PUMPING BLOOD OUT OF TOP OF CHAMBER. UPON FOLLOW-UP, THE PCT STATED A BLOOD LEAK OCCURRED FROM THE TOP OF THE BLOOD CHAMBER ONE HOUR AFTER INITIATION OF TREATMENT. THE MACHINE, A 2008T, ALARMED WITH AN ARTERIAL BLOOD LEAK ALERT. PER PCT THE BLOOD LEAKED FROM THE TOP CAP OF THE BLOOD LEAK DETECTOR CHAMBER. PER PCT THE TOP CAP REMAINED INTACT AND IT WAS UNKNOWN WHAT CAUSED THE LEAK TO OCCUR. A FRESENIUS 2008T HEMODIALYSIS MACHINE AND FRESENIUS DIALYZER WERE BEING USED DURING THE INCIDENT. BLOOD TEST STRIPS WERE NOT REQUIRED OR USED. THE PATIENT'S BLOOD WAS RETURNED FROM THE ARTERIAL SIDE OF THE SET AND THE ESTIMATED BLOOD LOSS (EBL) WAS 100ML. IMMEDIATELY FOLLOWING THE EVENT, THE TREATMENT WAS HALTED AND THE PATIENT WAS RE-SETUP WITH A NEW DIALYZER AND BLOODLINES AND COMPLETED THEIR TREATMENT ON THE SAME MACHINE. THE PCT CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE COMBISET WAS AVAILABLE TO BE RETURNED FOR EVALUATION.