COMBISET BLOODLINE

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED A COMIBSET BLOODLINE TRANSDUCER SEPARATED FROM LINE DURING TREATMENT. THE PATIENT WAS ON TREATMENT FOR OVER 1 HOUR 40 MINUTES. UPON FOLLOW-UP, THE CM STATED A HEMODIALYSIS (HD) PATIENT WAS ALMOST TWO HOURS INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE (S/N (B)(6) WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND THE PATIENT CARE TECHNICIAN (PCT) NOTICED THE TUBING THAT GOES INTO THE VENOUS TRANSDUCER CHAMBER HAD DETACHED AND WAS LEAKING BLOOD. TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT'S BLOOD WAS UNABLE TO BE RETURNED. THE CM CONFIRMED THAT THE MACHINE WAS NOT AFFECTED BUT WAS REMOVED FROM SERVICE AS BLOOD CAME INTO CONTACT WITH THE MACHINE. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. A FRESENIUS 180NRE DIALYZER WAS USED FOR TREATMENT. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS UNABLE TO BE ESTIMATED. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT DID NOT RESUME TREATMENT ON THE DAY OF THE REPORTED EVENT AND RETURNED THE FOLLOWING MORNING TO RESUME AND COMPLETE TREATMENT 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.

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED A COMIBSET BLOODLINE TRANSDUCER SEPARATED FROM LINE DURING TREATMENT. THE PATIENT WAS ON TREATMENT FOR OVER 1 HOUR 40 MINUTES. UPON FOLLOW-UP, THE CM STATED A HEMODIALYSIS (HD) PATIENT WAS ALMOST TWO HOURS INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE (S/N (B)(6)) WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND THE PATIENT CARE TECHNICIAN (PCT) NOTICED THE TUBING THAT GOES INTO THE VENOUS TRANSDUCER CHAMBER HAD DETACHED AND WAS LEAKING BLOOD. TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT'S BLOOD WAS UNABLE TO BE RETURNED. THE CM CONFIRMED THAT THE MACHINE WAS NOT AFFECTED BUT WAS REMOVED FROM SERVICE AS BLOOD CAME INTO CONTACT WITH THE MACHINE. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. A FRESENIUS 180NRE DIALYZER WAS USED FOR TREATMENT. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS UNABLE TO BE ESTIMATED. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT DID NOT RESUME TREATMENT ON THE DAY OF THE REPORTED EVENT AND RETURNED THE FOLLOWING MORNING TO RESUME AND COMPLETE TREATMENT 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.