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.

Description of Event or Problem

A USER FACILITY CLINICAL COORDINATOR REPORTED THAT A CLIC BLOOD CHAMBER LEAKED BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. BLOOD WAS VISUALLY OBSERVED LEAKING EXTERNALLY FROM THE EXTENDED PIECE ON THE TOP OF THE CLIC BLOOD CHAMBER. THE LEAK WAS REPORTEDLY COMING FROM THE CENTER OF THE TOP PIECE, HOWEVER, THERE WAS NO VISIBLE DAMAGE ON THE DEVICE. NO LEAK WAS NOTED DURING THE PRIMING PHASE, AND CONNECTIONS ON BOTH ENDS OF THE DEVICE WERE PROPERLY TIGHTENED AND SECURE. THE BLOOD LEAK WAS IDENTIFIED TOWARDS THE END OF THE PATIENT¿S 3.5-HOUR TREATMENT, AS THEY WERE BEING RINSED BACK. MOST OF THE PATIENT¿S BLOOD WAS RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 10 ML. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T MACHINE AND WAS USING FRESENIUS BLOODLINES AND A FRESENIUS OPTIFLUX DIALYZER. THERE WERE NO MACHINE ALARMS AND BLOOD TEST STRIPS WERE NOT USED. THE PATIENT COMPLETED THEIR TREATMENT ON THE MACHINE. IT WAS 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 COMPLAINT DEVICE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION WAS IT WAS REPORTEDLY DISCARDED.