MDR event

Additional Manufacturer Narrative

BOTH FACILITY'S BIOMEDICAL ENGINEER AND GAMBRO GTS REP INSPECTED THE MACHINE AND FOUND THAT IT PERFORMED ACCORDING TO MFR'S SPECIFICATIONS. THE MACHINE IS BACK IN SERVICE WITH NO REPORTED PROBLEMS. FACILITY USED THE TEDO CATHETER ACCESS DEVICE, A PLASTIC AND SILICONE SCREW-ON CATHETER CONNECTION THAT ALLOWS THE BLOOD TUBING SET TO BE FASTENED ONTO THE PT'S CATHETER WITHOUT USING CAPS OR NEEDLES. IT IS USED TO REDUCE NOSOCOMIAL INFECTIONS. THE TEDO CATHETER ACCESS DEVICE IS CHANGED ON MONDAYS IN THIS FACILITY AND THIS INCIDENT HAPPENED ON A SATURDAY. FACILITY'S NURSE MGR STATED THAT THERE WERE NO LOOSE CONNECTIONS OR CRACKS IN THE BLOOD TUBING SET AS THEY WERE CHECKED BEFORE AND AFTER THIS EVENT. THIS EVENT WAS REPORTED TO MFR OF THE TEDO CATHETER ACCESS DEVICE, TOO. BASED UPON THE AVAILABLE INFO AND THE UNAVAILABILITY OF THE BLOOD TUBING SET, A CONCLUSION AS TO WHETHER THIS WAS A TRUE AIR EMBOLI OR SOME OTHER EVENT CANNOT BE REACHED AT THIS TIME. BASED UPON THE CURRENT INFO PROVIDED THE TECHNICAL INVESTIGATION ON THE PART IS STILL IN PROGRESS. IF ANY ADDITIONAL INFO IS RECEIVED AS RESULT OF THE TECHNICAL INVESTIGATION, A FOLLOW-UP REPORT WILL BE PROVIDED. CURRENTLY GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT.