CLIC BLOOD CHAMBER

Additional Manufacturer Narrative

PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE 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 CLINIC MANAGER (CM) REPORTED A BLOOD LEAK THAT OCCURRED APPROXIMATELY SIXTY TO NINETY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS OBSERVED LEAKING EXTERNALLY NEAR THE CONNECTION POINT OF THE CLIC BLOOD CHAMBER TO THE DIALYZER, ON THE OUTSIDE WALL OF THE CLIC BLOOD CHAMBER¿S THREADING. THE CLIC BLOOD CHAMBER WAS DISCARDED IN A BIOHAZARD BIN BEFORE IT WAS CLOSELY EXAMINED, AND IT WAS UNKNOWN IF THERE WAS ANY DAMAGE ON THE DEVICE. THE CM REPORTED THAT THE BLOOD CHAMBER WAS SCREWED-ON TIGHTLY DURING THE SET UP. HOWEVER, WHEN THE DEVICE WAS UNSCREWED FROM THE DIALYZER, THE STAFF NOTICED THAT THE CONNECTION HAD LOOSENED. THE CM STATED THERE WERE NO MACHINE ALARMS, AND THERE WERE NO OBSERVED LEAKS DURING THE PRIMING PHASE. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T MACHINE AND UTILIZING AN OPTIFLUX 180NRE DIALYZER WITH COMBI SET BLOODLINES. THE DIALYZER WAS ALSO DISCARDED, AND A LOT NUMBER FOR THE PRODUCT COULD NOT BE PROVIDED. THERE WAS NO REPORTED DAMAGE IDENTIFIED ON THE DIALYZER. AFTER THE BLOOD LEAK WAS OBSERVED, THE PATIENT¿S TREATMENT WAS DISCONTINUED AND THEIR BLOOD WAS NOT RETURNED. THE ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 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 PATIENT WAS ABLE TO COMPLETE TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. NO SAMPLES ARE AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.