CLIC BLOOD CHAMBER

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A SHIPPING HISTORY SEARCH WAS PERFORMED ON LOTS DELIVERED TO THE CUSTOMER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. ACCORDING TO THE SEARCH RESULTS, THE REPORTED CATALOG NUMBER WAS NOT DELIVERED DURING THE SELECTED TIME FRAME. AS A LOT NUMBER COULD NOT BE DETERMINED, DEVICE HISTORY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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 REGISTERED NURSE (RN) REPORTED THAT A CLIC BLOOD CHAMBER LEAKED BLOOD APPROXIMATELY FIFTEEN MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD WAS LEAKING EXTERNALLY FROM A ¿SMALL CRACK¿ IDENTIFIED ¿IN THE CIRCLE/CLEAR SENSOR¿ [SIC]. THE MACHINE, A FRESENIUS 2008T, DID NOT ALARM. THE PATIENT WAS DIALYZING WITH FRESENIUS BLOODLINES AND A FRESENIUS OPTIFLUX DIALYZER. BLOOD LEAK TEST STRIPS WERE NOT USED. NO DAMAGE WAS IDENTIFIED ON THE DIALYZER OR THE BLOODLINES. THE LOT NUMBER FOR THE CLIC BLOOD CHAMBER WAS UNKNOWN. NO LEAKS WERE IDENTIFIED DURING PRIMING. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 15 TO 20 ML. 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 PATIENT CONTINUED AND COMPLETED TREATMENT AFTER THE CLIC DEVICE WAS REPLACED. THE DEVICE WAS REPORTEDLY DISCARDED; NO SAMPLE AVAILABLE FOR EVALUATION.