CLIC BLOOD CHAMBER

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE FACILITY FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL CLIC BLOOD CHAMBERS SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR 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 CLINIC MANAGER (CM) REPORTED THAT A CLIC BLOOD CHAMBER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE CM CONFIRMED BLOOD WAS OBSERVED LEAKING EXTERNALLY FROM THE CLIC BLOOD CHAMBER. THE CM WAS UNSURE WHICH END OF CLIC BLOOD CHAMBER THE LEAK WAS COMING FROM. HOWEVER, THE CM WAS ADAMANT THAT THE LEAK CAME FROM THIS DEVICE AND NOT FROM THE DIALYZER OR THE BLOODLINE. THE PATIENT WAS DIALYZING ON A B. BRAUN HD MACHINE, WITH A B. BRAUN STREAMLINE BLOODLINE AND A FRESENIUS OPTIFLUX DIALYZER. THE LEAK REPORTEDLY OCCURRED WITHIN THE FIRST THIRTY MINUTES OF TREATMENT. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES FOUND ON THE CLIC DEVICE PRIOR TO OR AFTER USE. ADDITIONALLY, IT WAS UNKNOWN IF THERE WERE ANY MACHINE ALARMS DURING THE TREATMENT. THE CM STATED THEY ARE IN THE PROCESS OF RE-EDUCATING THE STAFF ON FULLY ENGAGING THE CLIC BLOOD CHAMBERS DURING SETUP, TO ENSURE THEY ARE SECURE. THE CM WAS UNSURE IF THE LEAKING WAS DUE TO OPERATOR ERROR OR IF THE CONNECTION WAS LOOSENED AS THE TUBING WARMED UP. AFTER THE BLOOD LEAK WAS NOTED, THE PATIENT¿S TREATMENT WAS PAUSED. THE BLOOD IN THE CLOSED CIRCUIT WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS REPORTED TO BE 320 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 COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE COMPLAINT DEVICE WAS DISCARDED AND THE LOT NUMBER IN USE COULD NOT BE DETERMINED.