COMBISET ACCESS FLOW REVERSE CON TWISTER

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE COMBISET BLOODLINES AND NON-FRESENIUS DIALYZER CLOTTED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT ON A 2008T MACHINE. THE CM NOTED THAT THE STAFF WAS STRUGGLING WITH MANUAL SET-UPS WHEN THE AUTO PRIME FEATURE COULD ALSO BE USED. TREATMENT WAS PAUSED AND RE-SETUP WITH NEW SUPPLIES THEN RESTARTED WITH THE AUTO PRIME FEATURE. ADDITIONAL INFORMATION WAS OBTAINED FROM THE CM DURING FOLLOW-UP. THE CM STATED THAT APPROXIMATELY 2-3 HOURS INTO A PATIENT'S HEMODIALYSIS (HD) ON A 2008T MACHINE THE SUPPLIES CLOTTED. THE CM ATTRIBUTED THE REPORTED ISSUE TO USER ERROR WITH THE MANUAL SETUP OF THE 2008T MACHINE. THE CM STATED THAT THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE CM STATED THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE CM CONFIRMED THAT THE PATIENT'S BLOOD FLOW RATE (BFR) OR DIALYSIS FLOW RATE (DFR) DID NOT IMPACT THE REPORTED ISSUE. ADDITIONALLY NO AIR LEAKS WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE CLOTTING. NO PARTS WERE 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.

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE COMBISET BLOODLINES AND NON-FRESENIUS DIALYZER CLOTTED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT ON A 2008T MACHINE. THE CM NOTED THAT THE STAFF WAS STRUGGLING WITH MANUAL SET-UPS WHEN THE AUTO PRIME FEATURE COULD ALSO BE USED. TREATMENT WAS PAUSED AND RE-SETUP WITH NEW SUPPLIES THEN RESTARTED WITH THE AUTO PRIME FEATURE. ADDITIONAL INFORMATION WAS OBTAINED FROM THE CM DURING FOLLOW-UP. THE CM STATED THAT APPROXIMATELY 2-3 HOURS INTO A PATIENT'S HEMODIALYSIS (HD) ON A 2008T MACHINE THE SUPPLIES CLOTTED. THE CM ATTRIBUTED THE REPORTED ISSUE TO USER ERROR WITH THE MANUAL SETUP OF THE 2008T MACHINE. THE CM STATED THAT THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE CM STATED THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE CM CONFIRMED THAT THE PATIENT'S BLOOD FLOW RATE (BFR) OR DIALYSIS FLOW RATE (DFR) DID NOT IMPACT THE REPORTED ISSUE. ADDITIONALLY NO AIR LEAKS WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE CLOTTING. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE CUSTOMER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS COMBISET BLOODLINES SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR 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.