COMBISET ACCESS FLOW REVERSE CON TWISTER

Description of Event or Problem

A USER FACILITY CLINICAL MANAGER (CM) REPORTED TO FRESENIUS THAT BLOOD WAS OBSERVED DRIPPING FROM THE BLOOD PUMP SEGMENT OF THE FRESENIUS BLOODLINES APPROXIMATELY TWO HOURS AFTER THE INITIATION OF HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE CM. THE CM STATED THAT THE 2008T MACHINE ALSO ALARMED WITH AN AIR DETECTOR MESSAGE. TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 250 ML. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE LEAK. TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE MACHINE WAS EVALUATED BY THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) AND DETERMINED TO BE WORKING AS INTENDED. UPON CLOSER INSPECTION OF THE ORIGINAL BLOODLINES A TEAR WAS IDENTIFIED IN THE BLOOD PUMP TUBING SEGMENT. THE COMPLAINT SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

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

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 CLINICAL MANAGER (CM) REPORTED TO FRESENIUS THAT BLOOD WAS OBSERVED DRIPPING FROM THE BLOOD PUMP SEGMENT OF THE FRESENIUS BLOODLINES APPROXIMATELY TWO HOURS AFTER THE INITIATION OF HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE CM. THE CM STATED THAT THE 2008T MACHINE ALSO ALARMED WITH AN AIR DETECTOR MESSAGE. TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 250 ML. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE LEAK. TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE MACHINE WAS EVALUATED BY THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) AND DETERMINED TO BE WORKING AS INTENDED. UPON CLOSER INSPECTION OF THE ORIGINAL BLOODLINES A TEAR WAS IDENTIFIED IN THE BLOOD PUMP TUBING SEGMENT. THE COMPLAINT SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.