COMBISET SMARTECH BLOODLINE (NO HEPARIN)

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 CLINICAL MANAGER (CM) REPORTED THAT A LARGE AMOUNT OF AIR ENTERED A COMBISET SMARTECH BLOODLINE AT THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE STAFF NOTICED AIR IN THE COMBISET, BUT THEY COULD NOT IDENTIFY WHERE THE BREACH WAS. THERE WERE NO ALARMS FROM THE MACHINE, A FRESENIUS 2008T. HOWEVER, THE CM SAID THIS WAS BECAUSE THE AIR WAS NOTICED SO QUICKLY. THE DECISION WAS MADE TO STOP THE TREATMENT AND THE PATIENT¿S BLOOD WAS NOT RETURNED. ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 100ML. WHILE INSPECTING THE COMBISET AFTER IT WAS DISCONNECTED, A SMALL AMOUNT OF SALINE LEAKED FROM THE ARTERIAL LINE AT THE LUER LOCK HUB (WHERE THE PATIENT¿S CATHETER CONNECTS). THERE WAS NO VISIBLE DEFECT NOTED AT THE LEAK LOCATION. THE CM CONFIRMED THERE WERE NO ISSUES DURING THE PRIME. IT WAS CONCLUDED THAT AIR ENTERED THE CIRCUIT AT THE CONNECTION WHERE THE ARTERIAL LINE ADHERES TO THE (RED) LUER LOCK CONNECTOR. THE CM 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 WAS ABLE TO COMPLETE THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE SAMPLE WAS CONFIRMED TO BE AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.