COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D10, H3 PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER, PREVENTING A PHYSICAL EVALUATION FROM BEING PERFORMED. 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. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A BLOOD LEAK THAT OCCURRED WITH A COMBI SET APPROXIMATELY 90 MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT WAS ON A FRESENIUS 2008T MACHINE AND DIALYZING WITH A FRESENIUS DIALYZER, HOWEVER ADDITIONAL PRODUCT INFORMATION WAS NOT PROVIDED. THE BIOMEDICAL TECHNICIAN (BIOMED) VISUALLY OBSERVED A DROP OF BLOOD BENEATH THE BLOOD PUMP. THE BIOMED WENT TO ADJUST THE HEPARIN LINE AND WAS SPRAYED WITH BLOOD. TREATMENT WAS PAUSED AND THE LINE WAS CLAMPED. DURING FOLLOW-UP WITH THE USER FACILITY, THE CLINIC MANAGER (CM) STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 180ML. THE CM STATED THERE WERE NO LOOSE CONNECTIONS, DEFECT, OR DAMAGE FOUND ON THE COMBI SET. THERE WERE NO ISSUES ENCOUNTERED WITH THE COMBI SET DURING PRIME. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT DEVICES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.