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-CONFORMANCE'S 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. BLOOD 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. ONE OF THE NURSES AT THE FACILITY REPORTED TO THE CM THAT A CRACK WAS VISIBLE ON THE OUTSIDE OF THE CLIC BLOOD CHAMBER, AT THE LOCATION OF THE REPORTED LEAK. THE CM CONFIRMED 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 DIALYZER WITH COMBI SET BLOODLINES. 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 ELECTED NOT TO COMPLETE THEIR TREATMENT. THE CM CONFIRMED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS OR EXPERIENCE ANY OTHER ISSUES DUE TO THE INCOMPLETE TREATMENT. THE CLIC BLOOD CHAMBER WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION; IT WAS REPORTEDLY DISCARDED IN A BIOHAZARD BIN FOLLOWING THE EVENT.