COMBISET BLOODLINE

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED A HEMODIALYSIS (HD) PATIENT WAS ON TREATMENT FOR APPROXIMATELY 30 MINUTES AND THE MACHINE BEGAN TO ALARM AIR IN LINES. UPON INVESTIGATION THERE WAS A HOLE FOUND IN THE TUBING. NO AIR REACHED THE PATIENT. THE PATIENT'S BLOOD WAS UNABLE TO BE RETURNED AND THE TUBING WAS DISCARDED. UPON FOLLOW-UP, THE CM STATED A HEMODIALYSIS (HD) PATIENT WAS THIRTY MINUTES INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR IN LINES ALARM, AND STAFF NOTICED BLOOD IN THE BLOOD PUMP AREA. TREATMENT WAS HALTED AND THE STAFF REPORTED A SMALL HOLE IN THE LINE OF THE TUBING. THE CM STATED IT WAS UNKNOWN IF THE BLOOD PUMP ROTOR WAS ORIGINAL TO THE MACHINE AND IF THE BLOOD PUMP ROTOR HAD BEEN PREVIOUSLY REPLACED (PRODUCT, LOT NUMBER UNKNOWN). AN INSPECTION OF THE ROTOR WAS PERFORMED AND THERE WERE NO VISIBLE SIGNS OF DAMAGE OR WEAR. THE PINS WERE NOT LOOSE AND THERE WAS NOTHING VISIBLE THAT WOULD HAVE CAUSED IT TO DAMAGE THE TUBING. THE MACHINE WAS NOT REMOVED FROM THE FLOOR AND REMAINED IN SERVICE. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. FOLLOWING THE EVENT, THE CM STATED 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.

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 HEMODIALYSIS (HD) PATIENT WAS ON TREATMENT FOR APPROXIMATELY 30 MINUTES AND THE MACHINE BEGAN TO ALARM AIR IN LINES. UPON INVESTIGATION THERE WAS A HOLE FOUND IN THE TUBING. NO AIR REACHED THE PATIENT. THE PATIENT'S BLOOD WAS UNABLE TO BE RETURNED AND THE TUBING WAS DISCARDED. UPON FOLLOW-UP, THE CM STATED A HEMODIALYSIS (HD) PATIENT WAS THIRTY MINUTES INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR IN LINES ALARM, AND STAFF NOTICED BLOOD IN THE BLOOD PUMP AREA. TREATMENT WAS HALTED AND THE STAFF REPORTED A SMALL HOLE IN THE LINE OF THE TUBING. THE CM STATED IT WAS UNKNOWN IF THE BLOOD PUMP ROTOR WAS ORIGINAL TO THE MACHINE AND IF THE BLOOD PUMP ROTOR HAD BEEN PREVIOUSLY REPLACED (PRODUCT, LOT NUMBER UNKNOWN). AN INSPECTION OF THE ROTOR WAS PERFORMED AND THERE WERE NO VISIBLE SIGNS OF DAMAGE OR WEAR. THE PINS WERE NOT LOOSE AND THERE WAS NOTHING VISIBLE THAT WOULD HAVE CAUSED IT TO DAMAGE THE TUBING. THE MACHINE WAS NOT REMOVED FROM THE FLOOR AND REMAINED IN SERVICE. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. FOLLOWING THE EVENT, THE CM STATED 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.