COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

PLANT INVESTIGATION: A SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE SAMPLE WAS RECEIVED WITHOUT ORIGINAL PACKAGING. THE COMPLAINT PRODUCT SAMPLE WAS DISINFECTED. DURING THE DISINFECTION A LEAK WAS FOUND FROM THE RED ¿T¿ CONNECTOR, NO HEPARIN LINE WAS FOUND. ADDITIONALLY, SAMPLE WAS VISUALLY INSPECTED. DURING THE VISUAL INSPECTION IT WAS FOUND THAT THE HEPARIN LINE WAS NOT RECEIVED WITH THE COMBI SET. ALSO, SOLVENT CAN BE SEEN INSIDE THE CONNECTOR CAVITY DUE TO CLOSE INSPECTION OF THE CONNECTOR UNDER A MICROSCOPE. THE ALLEGED FAILURE MODE WAS CONFIRMED DURING SAMPLE EVALUATION. THIS KIND OF FAILURE MODE COULD BE ATTRIBUTED TO AN IMPROPER ASSEMBLY BY THE OPERATOR DUE TO NOT FOLLOWING THE WORK INSTRUCTION, NOT APPLYING SOLVENT CORRECTLY IN THE COMPONENTS DURING THE MANUFACTURING PROCESS (LACK OF SOLVENT APPLICATION) OR DUE TO A LACK OF SOLVENT DURING THE ASSEMBLY OF THE COMPONENTS (DISPENSER MALFUNCTIONING). A DHR REVIEW WAS PERFORMED FOR THE INVOLVED LOT OF THE PRODUCT AND THERE WERE NO NON-CONFORMANCES, ANY ASSOCIATED REWORK OR DEVIATION RELATED WITH THE ALLEGED FAILURE MODE DURING THE ASSEMBLY OF THE LOT INVOLVED. ALL THE APPLICABLE IN-PROCESS AND FINAL INSPECTION TESTS WERE FOUND WITH ACCEPTABLE RESULTS.

Description of Event or Problem

A USER FACILITY REGISTERED NURSE (RN) REPORTED A BLOOD LEAK FROM THE HEPARIN LINE SEPARATING ON THE FRESENIUS COMBISET BLOODLINES DURING THE PATIENT¿S HEMODIALYSIS TREATMENT. THERE WERE NO ISSUES DURING PRIMING REPORTED. UPON FOLLOW UP WITH THE CHARGE NURSE, IT WAS CONFIRMED THAT THE COMBISET WAS NOT DROPPED AT ALL PRIOR TO USE, AND THERE WERE NO DEFECTS NOTED ON THE DEVICE DURING SET UP. THE MACHINE USED DURING TREATMENT WAS A FRESENIUS 2008T MACHINE AND THE DIALYZER USED DURING TREATMENT WAS A FRESENIUS DIALYZER. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 100 ML. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. IT WAS CONFIRMED THAT THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY REGISTERED NURSE (RN) REPORTED A BLOOD LEAK FROM THE HEPARIN LINE SEPARATING ON THE FRESENIUS COMBISET BLOODLINES DURING THE PATIENT¿S HEMODIALYSIS TREATMENT. THERE WERE NO ISSUES DURING PRIMING REPORTED. UPON FOLLOW UP WITH THE CHARGE NURSE, IT WAS CONFIRMED THAT THE COMBISET WAS NOT DROPPED AT ALL PRIOR TO USE, AND THERE WERE NO DEFECTS NOTED ON THE DEVICE DURING SET UP. THE MACHINE USED DURING TREATMENT WAS A FRESENIUS 2008T MACHINE AND THE DIALYZER USED DURING TREATMENT WAS A FRESENIUS DIALYZER. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 100 ML. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. IT WAS CONFIRMED THAT THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.