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.

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 REPORTED THAT A CLIC BLOOD CHAMBER BLOOD LEAK AROUND THE EDGES DURING A PATIENT¿S HEMODIALYSIS TREATMENT. THE CLIC CHAMBER WAS REMOVED. THE PATIENT ESTIMATED BLOOD LOSS WAS 10-20 CC. UPON FOLLOW UP, THE BLOOD LEAK OCCURRED AN HOUR INTO TREATMENT. BLOOD LEAK TEST STRIPS WERE NOT USED AS THE LEAK WAS VISUALLY OBSERVED. THE CLINIC MANAGER STATED THAT FRESENIUS BLOODLINES, DIALYZERS AND FRESENIUS 2008T WERE USED FOR TREATMENT. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT¿S TREATMENT COMPLETED SUCCESSFULLY ON THE SAME MACHINE WITH NEW SUPPLIES. THE CLIC CHAMBER WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.