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 CLINIC MANAGER REPORTED THAT BLOOD TINGED SALINE WAS OBSERVED COMING FROM THE DIALYZER WITH THE ARTERIAL LINE DISCONNECTED FROM THE ARTERIAL PORT DURING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE HAD A TMP ALARM UPON FLUSHING THE SYSTEM WITH NORMAL SALINE AND THE VENOUS CHAMBER ALARMED AIR DETECTOR. UPON FOLLOW UP, THE CLINIC MANAGER STATED THAT THE BLOOD LEAK WAS OBSERVED FROM THE CRITLINE. THE CRITLINE SEPARATED FROM THE DIALYZER TOP 2 HOURS INTO THE PATIENT HEMODIALYSIS TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 ML. THE CLINIC MANAGER CONFIRMED THE TMP ALARM FROM THE FRESENIUS 2008T MACHINE DURING THE PATIENT¿S TREATMENT. THE CLINIC MANAGER CONFIRMED THAT FRESENIUS BLOODLINES AND DIALYZERS WERE USED DURING TREATMENT. BLOOD LEAK TEST STRIPS WERE NOT USED AS THE LEAK WAS VISUALLY OBSERVED. THE PATIENT COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

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.