COMBISET BLOODLINE

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED UPON START OF THE TREATMENT, IT WAS NOTED THAT THE VENOUS DRIP CHAMBER HAD AIR AND BLOOD LEAKING FROM THE SEAL AROUND THE TOP OF THE VENOUS CHAMBER. THERE WAS MINIMAL BLOOD LOSS (LESS THAN 100ML) TO THE PATIENT AS THIS WAS CAUGHT DURING INITIATION OF TREATMENT. UPON FOLLOW-UP, THE CM REPORTED A HEMODIALYSIS (HD) PATIENT WAS AT THE INITIATION OF DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND STAFF NOTICED THE VENOUS DRIP CHAMBER HAD AIR AND BLOOD LEAKING FROM THE SEAL AROUND THE TOP OF THE VENOUS CHAMBER. TREATMENT WAS HALTED. THE CM CONFIRMED THAT THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AS THE LEAK WAS OBSERVED FROM THE BLOODLINE SET. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. A FRESENIUS 180NRE DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS ABLE TO BE RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS MINIMAL AND LESS THAN 100 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS DISCARDED AND WAS NO LONGER 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.

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED UPON START OF THE TREATMENT, IT WAS NOTED THAT THE VENOUS DRIP CHAMBER HAD AIR AND BLOOD LEAKING FROM THE SEAL AROUND THE TOP OF THE VENOUS CHAMBER. THERE WAS MINIMAL BLOOD LOSS (LESS THAN 100ML) TO THE PATIENT AS THIS WAS CAUGHT DURING INITIATION OF TREATMENT. UPON FOLLOW-UP, THE CM REPORTED A HEMODIALYSIS (HD) PATIENT WAS AT THE INITIATION OF DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND STAFF NOTICED THE VENOUS DRIP CHAMBER HAD AIR AND BLOOD LEAKING FROM THE SEAL AROUND THE TOP OF THE VENOUS CHAMBER. TREATMENT WAS HALTED. THE CM CONFIRMED THAT THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AS THE LEAK WAS OBSERVED FROM THE BLOODLINE SET. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. A FRESENIUS 180NRE DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS ABLE TO BE RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS MINIMAL AND LESS THAN 100 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

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