COMBISET SMARTECH BLOODLINE

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 HEMODIALYSIS (HD) TECHNICIAN REPORTED BLOOD LEAKING FROM A FRESENIUS COMBISET DURING A PATIENT¿S TREATMENT. THE LEAK WAS COMING FROM THE ¿TOP OF THE ARTERIAL SIDE, THROUGH THE ROUND EDGES¿ OF THE INTEGRATED CLIC BLOOD CHAMBER. IT WAS REPORTED THAT A TINY SPOT OF DRIED BLOOD WAS NOTICED ON THE EXTERIOR OF THE TUBING SET APPROXIMATELY TWO HOURS INTO THE PATIENT¿S HD TREATMENT. THERE WAS NO VISIBLE DAMAGE NOTED ON THE DEVICE. THE DRIED BLOOD WAS FOUND JUST BELOW THE CONNECTION POINT ON THE TUBING SET. IT WAS SUSPECTED THAT THE CLIC BLOOD CHAMBER WAS NOT SEALED PROPERLY. BLOOD WAS NOT ACTIVELY LEAKING WHEN THIS WAS NOTICED. THE ESTIMATED BLOOD LESS WAS SAID TO BE LESS THAN 1 ML. THERE WERE NO MACHINE ALARMS DURING THE TREATMENT, AND NO OTHER ISSUES. THE PATIENT WAS ABLE TO CONTINUE AND COMPLETE THEIR TREATMENT WITH THE SAME SUPPLIES. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T MACHINE AND UTILIZING A FRESENIUS OPTIFLUX DIALYZER. THE COMBISET WAS NOT AVAILABLE FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. PHOTOS WERE TAKEN OF THE SAMPLE AND PROVIDED FOR REVIEW.

Additional Manufacturer Narrative

PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED BY THE USER FACILITY. IN THE PHOTOGRAPH, A CONFIRMED LEAK WAS VISIBLE IN THE LENS SEAL OF THE CLIC BLOOD CHAMBER. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED BASED ON THE PROVIDED PHOTOGRAPH.

Description of Event or Problem

A USER FACILITY HEMODIALYSIS (HD) TECHNICIAN REPORTED BLOOD LEAKING FROM A FRESENIUS COMBISET DURING A PATIENT¿S TREATMENT. THE LEAK WAS COMING FROM THE ¿TOP OF THE ARTERIAL SIDE, THROUGH THE ROUND EDGES¿ OF THE INTEGRATED CLIC BLOOD CHAMBER. IT WAS REPORTED THAT A TINY SPOT OF DRIED BLOOD WAS NOTICED ON THE EXTERIOR OF THE TUBING SET APPROXIMATELY TWO HOURS INTO THE PATIENT¿S HD TREATMENT. THERE WAS NO VISIBLE DAMAGE NOTED ON THE DEVICE. THE DRIED BLOOD WAS FOUND JUST BELOW THE CONNECTION POINT ON THE TUBING SET. IT WAS SUSPECTED THAT THE CLIC BLOOD CHAMBER WAS NOT SEALED PROPERLY. BLOOD WAS NOT ACTIVELY LEAKING WHEN THIS WAS NOTICED. THE ESTIMATED BLOOD LESS WAS SAID TO BE LESS THAN 1 ML. THERE WERE NO MACHINE ALARMS DURING THE TREATMENT, AND NO OTHER ISSUES. THE PATIENT WAS ABLE TO CONTINUE AND COMPLETE THEIR TREATMENT WITH THE SAME SUPPLIES. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T MACHINE AND UTILIZING A FRESENIUS OPTIFLUX DIALYZER. THE COMBISET WAS NOT AVAILABLE FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. PHOTOS WERE TAKEN OF THE SAMPLE AND PROVIDED FOR REVIEW.