CLIC BLOOD CHAMBER

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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED A CLIC BLOOD CHAMBER LEAK THAT OCCURRED APPROXIMATELY THIRTY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BIOMED STATED THE LEAK WAS TRACED TO A CRACK NEAR THE THREADING ON THE DEVICE. NO LEAK WAS OBSERVED DURING THE PRIME, AND ALL CONNECTIONS WERE REPORTEDLY SECURE. THE BLOOD LEAK WAS IDENTIFIED WHEN A ¿PUDDLE OF BLOOD¿ WAS NOTED AT THE BASE OF THE MACHINE. THE MACHINE, A FRESENIUS 2008T, DID NOT ALARM. A FRESENIUS OPTIFLUX DIALYZER WAS ALSO BEING USED IN CONJUNCTION WITH FRESENIUS COMBI SET BLOODLINES. THE BIOMED STATED THERE WAS NO DAMAGE IDENTIFIED ON THE DIALYZER OR THE BLOODLINES. AFTER THE PUDDLE OF BLOOD WAS IDENTIFIED, THE PATIENT¿S TREATMENT WAS HALTED, AND THE MAJORITY OF THEIR BLOOD WAS RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 100 ML. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. AFTER THE BLOOD WAS RETURNED, THE CLIC BLOOD CHAMBER WAS REMOVED FROM THE CIRCUIT, AND THE PATIENT¿S TREATMENT WAS CONTINUED UTILIZING THE SAME DIALYZER AND BLOODLINES. THE PATIENT COMPLETED THEIR TREATMENT ON THE SAME MACHINE AFTER REMOVAL OF THE BLOOD CHAMBER. THE BLOOD CHAMBER WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR A MANUFACTURER EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE DEVICE WAS NOT RETURNED IN THE ORIGINAL PACKAGING. DURING DISINFECTION OF THE SAMPLE, A LEAK WAS DETECTED. THE LEAK WAS COMING FROM THE DIN CONNECTOR, ON THE DIALYZER SIDE OF THE DEVICE JUST BELOW THE BLOOD CHAMBER. DURING VISUAL INSPECTION OF THE SAMPLE UNDER A MICROSCOPE, A LONGITUDINAL CRACK WAS IDENTIFIED AT THE LEAK LOCATION. 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. 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. DUE TO THE DEVICE DAMAGE IDENTIFIED DURING VISUAL INSPECTION AND THE OBSERVED LEAK THAT OCCURRED DURING DISINFECTION, THE INVESTIGATION INTO THE COMPLAINT WAS ABLE TO CONFIRM THE REPORTED EVENT.