COMBISET BLOODLINE

Description of Event or Problem

A USER FACILITY CHARGE NURSE (CN) REPORTED A TEAR IN THE BLOOD PUMP SEGMENT OF THE BLOODLINE, LEAKING BLOOD 3 HOURS INTO PATIENT TREATMENT. UPON FOLLOW-UP, THE CN STATED A HEMODIALYSIS (HD) PATIENT WAS ABOUT THREE HOURS INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND STAFF NOTICED BLOOD DRIPPING FROM THE BLOOD PUMP SECTION OF THE DIALYSIS TUBING LINE ON THE DIALYSIS MACHINE. TREATMENT WAS HALTED AND THE STAFF REPORTED A VISIBLE TEAR IN THE LINE OF THE TUBING. THE CN CONFIRMED THAT THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AS THE LEAK WAS OBSERVED FROM THE TUBING LINE ITSELF. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. THE CN STATED THE BLOOD PUMP ROTOR WAS INSPECTED WITH NO NOTED ISSUES AND INDICATED THE MACHINE HAS REMAINED IN SERVICE. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE CN STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300ML. THE CN CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. FOLLOWING THE EVENT, THE CN STATED THE PATIENT DECLINED RE-SETTING WITH NEW SUPPLIES TO CONTINUE TREATMENT AND ENDED TREATMENT VOLUNTARILY. THE PATIENT RETURNED THE FOLLOWING MORNING AND COMPLETED 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 CHARGE NURSE (CN) REPORTED A TEAR IN THE BLOOD PUMP SEGMENT OF THE BLOODLINE, LEAKING BLOOD 3 HOURS INTO PATIENT TREATMENT. UPON FOLLOW-UP, THE CN STATED A HEMODIALYSIS (HD) PATIENT WAS ABOUT THREE HOURS INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND STAFF NOTICED BLOOD DRIPPING FROM THE BLOOD PUMP SECTION OF THE DIALYSIS TUBING LINE ON THE DIALYSIS MACHINE. TREATMENT WAS HALTED AND THE STAFF REPORTED A VISIBLE TEAR IN THE LINE OF THE TUBING. THE CN CONFIRMED THAT THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AS THE LEAK WAS OBSERVED FROM THE TUBING LINE ITSELF. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. THE CN STATED THE BLOOD PUMP ROTOR WAS INSPECTED WITH NO NOTED ISSUES AND INDICATED THE MACHINE HAS REMAINED IN SERVICE. A FRESENIUS DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE CN STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300ML. THE CN CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. FOLLOWING THE EVENT, THE CN STATED THE PATIENT DECLINED RE-SETTING WITH NEW SUPPLIES TO CONTINUE TREATMENT AND ENDED TREATMENT VOLUNTARILY. THE PATIENT RETURNED THE FOLLOWING MORNING AND COMPLETED 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.