COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

PLANT INVESTIGATION: ALTHOUGH A SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION, TO DATE NO SAMPLE HAS BEEN RECEIVED. 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. SHOULD THE SAMPLE BE RETURNED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED CAPTURING THE UPDATED INVESTIGATION RESULTS.

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 CLINIC MANAGER (CM) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED APPROXIMATELY ONE HOUR AND FIFTEEN MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. BLOOD WAS OBSERVED LEAKING EXTERNALLY FROM THE ACCESS FLOW TWIST SEGMENT OF THE BLOODLINE. PER THE CM, THE PATIENT HAD JUST COMPLETED THE ACCESS FLOW PORTION OF THEIR TREATMENT. THE BLOODLINE STARTED LEAKING AFTER THEY SWITCHED TO RUNNING THE REGULAR PART OF THE TREATMENT. THE PATIENT REPORTEDLY RUNS AT 300 ML/MIN AND THEY WERE ATTEMPTING TO INCREASE THE SPEED TO 450 ML/MIN. THERE WERE NO MACHINE ALARMS REPORTED. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T HD MACHINE, AND UTILIZING AN OPTIFLUX 160NR DIALYZER. THERE WERE NO LOOSE CONNECTIONS OR DEFECTS NOTED ON THE COMBI SET, AND NO LEAKS WERE NOTED DURING THE PRIMING PHASE. AFTER THE BLOOD LEAK WAS OBSERVED, THE TREATMENT WAS DISCONTINUED. THE PATIENT WAS MOVED TO ANOTHER MACHINE WHERE THEY COMPLETED TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES. BETWEEN THE BLOOD CONTAINED IN THE LINES AND WHAT HAD LEAKED ONTO THE FLOOR, THE CM STATED THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 350 TO 400 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE COMBI SET WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR A MANUFACTURER EVALUATION.