COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. DURING VISUAL INSPECTION OF THE SAMPLE, A CRACK WAS IDENTIFIED ON THE ARTERIAL LUER LOCK (FEMALE) CONNECTOR. DURING DISINFECTION OF THE DEVICE, A LEAK WAS DETECTED COMING FROM THE LUER LOCK CONNECTOR, AT THE LOCATION OF THE OBSERVED CRACK. 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. HOWEVER, DUE TO THE CRACK IDENTIFIED ON THE LUER LOCK CONNECTOR, AND THE LEAK THAT OCCURRED DURING DISINFECTION OF THE DEVICE, THE INVESTIGATION INTO THE COMPLAINT WAS ABLE TO CONFIRM THE REPORTED EVENT.

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 HEMODIALYSIS (HD) USER FACILITY REPORTED A COMBI SET BLOOD LEAK THAT OCCURRED SHORTLY AFTER INITIATION OF A PATIENT¿S HD TREATMENT. THE BLOOD WAS REPORTED TO BE LEAKING FROM THE LUER LOCK CONNECTOR, CLOSE TO WHERE THE VENOUS TRANSDUCER CONNECTS. UPON FOLLOW UP, IT WAS REPORTED THAT A CRACK WAS IDENTIFIED ON THE LUER LOCK CONNECTOR. THIS WAS BELIEVED TO BE THE ORIGIN OF THE LEAK. THE PATIENT¿S TREATMENT WAS IMMEDIATELY HALTED AFTER THE LEAK WAS IDENTIFIED. THE LINES WERE CLAMPED TO PREVENT FURTHER LEAKAGE AND THE COMBI SET WAS REPLACED WITH A NEW ONE. THE PATIENT¿S BLOOD LOSS WAS MINIMAL; ESTIMATED BLOOD LOSS (EBL) WAS 10 ML. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T MACHINE AND WAS USING A FRESENIUS OPTIFLUX DIALYZER. THE MACHINE DID NOT ALARM. IT WAS CONFIRMED THAT THERE WAS NO PATIENT 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 THE COMBI SET WAS REPLACED WITH A NEW ONE. THE COMBI SET BLOODLINE WAS REPORTED TO BE AVAILABLE FOR A MANUFACTURER EVALUATION.