CLIC BLOOD CHAMBER

Description of Event or Problem

A USER FACILITY NURSE REPORTED THAT AN EXTERNAL BLOOD LEAK OCCURRED TWO HOURS INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS INITIALLY REPORTED THAT ¿A CRACK¿ WAS FOUND ON THE CLIC BLOOD CHAMBER. UPON FOLLOW-UP, IT WAS REPORTED THAT A COUPLE OF BLOOD DROPLETS WERE IDENTIFIED ON THE HD MACHINE WHICH WERE TRACED TO AN EXTERNAL LEAK FROM THE DIALYZER END CONNECTION OF THE CLIC BLOOD CHAMBER. AN EXTERNAL BLOOD LEAK WAS ALLEGED. REPORTEDLY, THE PATIENT¿S BLOOD HAD SEALED ITSELF OFF AT THE SITE OF THE LEAK. AS A RESULT, THE TREATMENT WAS CONTINUED AND COMPLETED WITH THE SAME SUPPLIES AND ON THE SAME MACHINE. DESPITE THE INITIAL ALLEGATION OF PHYSICAL DAMAGE, FOLLOW-UP CONFIRMED THAT NO CRACKS WERE VISUALLY IDENTIFIED ON THE CLIC BLOOD CHAMBER. THERE WERE NO MACHINE ALARMS ASSOCIATED WITH THE REPORTED FAILURE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 5 ML. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EFFECTS OR REQUIRED MEDICAL INTERVENTION. AS A PROPHYLACTIC MEASURE, THE PATIENT WAS ADMINISTERED AN ANTIBIOTIC INFUSION X1 (FURTHER DETAILS ON THIS WERE NOT PROVIDED). THE CLIC BLOOD CHAMBER WAS NOT AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION. HOWEVER, A PHOTO OF THE DEVICE CONNECTED TO THE DIALYZER WAS PROVIDED FOR REVIEW.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

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 NURSE REPORTED THAT AN EXTERNAL BLOOD LEAK OCCURRED TWO HOURS INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS INITIALLY REPORTED THAT ¿A CRACK¿ WAS FOUND ON THE CLIC BLOOD CHAMBER. UPON FOLLOW-UP, IT WAS REPORTED THAT A COUPLE OF BLOOD DROPLETS WERE IDENTIFIED ON THE HD MACHINE WHICH WERE TRACED TO AN EXTERNAL LEAK FROM THE DIALYZER END CONNECTION OF THE CLIC BLOOD CHAMBER. AN EXTERNAL BLOOD LEAK WAS ALLEGED. REPORTEDLY, THE PATIENT¿S BLOOD HAD SEALED ITSELF OFF AT THE SITE OF THE LEAK. AS A RESULT, THE TREATMENT WAS CONTINUED AND COMPLETED WITH THE SAME SUPPLIES AND ON THE SAME MACHINE. DESPITE THE INITIAL ALLEGATION OF PHYSICAL DAMAGE, FOLLOW-UP CONFIRMED THAT NO CRACKS WERE VISUALLY IDENTIFIED ON THE CLIC BLOOD CHAMBER. THERE WERE NO MACHINE ALARMS ASSOCIATED WITH THE REPORTED FAILURE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 5 ML. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EFFECTS OR REQUIRED MEDICAL INTERVENTION. AS A PROPHYLACTIC MEASURE, THE PATIENT WAS ADMINISTERED AN ANTIBIOTIC INFUSION X1 (FURTHER DETAILS ON THIS WERE NOT PROVIDED). THE CLIC BLOOD CHAMBER WAS NOT AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION. HOWEVER, A PHOTO OF THE DEVICE CONNECTED TO THE DIALYZER WAS PROVIDED FOR REVIEW.