COMBISET ACCESS FLOW REVERSE CON TWISTER

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 CLINICAL MANAGER (CM) REPORTED TO FRESENIUS THAT A SMALL SLIT WAS IDENTIFIED IN THE ARTERIAL CHAMBER TUBING OF THE COMBISET BLOODLINES WHICH LED TO AIR GETTING IN THE SYSTEM AND THE SYSTEM BEING DISPOSED. DURING FOLLOW-UP THE CM CONFIRMED THAT THE ISSUE OCCURRED DURING TREATMENT. A BLOOD LEAK WAS VISUALLY NOTED WHERE THE SLIT WAS DISCOVERED ON THE TUBING. THE 2008T MACHINE ALSO ALARMED WITH AN AIR DETECTED MESSAGE. TREATMENT WAS PAUSED. THE PATIENT'S BLOOD WAS RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. IT WAS INDICATED THAT THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. THE SUPPLIES WERE REPLACED IN ORDER TO CONTINUE TREATMENT. THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL 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.

Description of Event or Problem

A USER FACILITY CLINICAL MANAGER (CM) REPORTED TO FRESENIUS THAT A SMALL SLIT WAS IDENTIFIED IN THE ARTERIAL CHAMBER TUBING OF THE COMBISET BLOODLINES WHICH LED TO AIR GETTING IN THE SYSTEM AND THE SYSTEM BEING DISPOSED. DURING FOLLOW-UP THE CM CONFIRMED THAT THE ISSUE OCCURRED DURING TREATMENT. A BLOOD LEAK WAS VISUALLY NOTED WHERE THE SLIT WAS DISCOVERED ON THE TUBING. THE 2008T MACHINE ALSO ALARMED WITH AN AIR DETECTED MESSAGE. TREATMENT WAS PAUSED. THE PATIENT'S BLOOD WAS RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. IT WAS INDICATED THAT THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. THE SUPPLIES WERE REPLACED IN ORDER TO CONTINUE TREATMENT. THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY CLINICAL MANAGER (CM) REPORTED TO FRESENIUS THAT A SMALL SLIT WAS IDENTIFIED IN THE ARTERIAL CHAMBER TUBING OF THE COMBISET BLOODLINES WHICH LED TO AIR GETTING IN THE SYSTEM AND THE SYSTEM BEING DISPOSED. DURING FOLLOW-UP THE CM CONFIRMED THAT THE ISSUE OCCURRED DURING TREATMENT. A BLOOD LEAK WAS VISUALLY NOTED WHERE THE SLIT WAS DISCOVERED ON THE TUBING. THE 2008T MACHINE ALSO ALARMED WITH AN AIR DETECTED MESSAGE. TREATMENT WAS PAUSED. THE PATIENT'S BLOOD WAS RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. IT WAS INDICATED THAT THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. THE SUPPLIES WERE REPLACED IN ORDER TO CONTINUE TREATMENT. THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE MANUFACTURER RECEIVED ONE COMPLAINT SAMPLE FOR PHYSICAL EVALUATION (WITH PRODUCT NUMBER 03-2794-0 FROM LOT NUMBER 21LR01294). AS THE COMPLAINT PRODUCT SAMPLE WAS BEING DISINFECTED AND PREPARED FOR ANALYSIS, A LEAK WAS FOUND ON THE TUBING ASSEMBLED TO THE CAP OF THE ARTERIAL CHAMBER. DURING A VISUAL INSPECTION, IT WAS NOTED THAT THE TUBING FROM THE CAP OF THE ARTERIAL CHAMBER WAS NOT ASSEMBLED PROPERLY. THERE WAS A DRYNESS CHANNEL AND IT WAS DETERMINED THAT THIS GAP CAUSED THE REPORTED LEAK. THE POTENTIAL CAUSES OF THIS KIND OF FAILURE MODE INCLUDE INCORRECT ASSEMBLY TECHNIQUE, AN UNQUALIFIED OPERATOR, UNCLEAR WORK INSTRUCTION, DISPENSERS NOT APPROPRIATELY WORKING IN THE ASSEMBLY PROCESS, A LACK OF SOLVENT IN THE DISPENSER, AND SOLVENT APPLICATION TECHNIQUE. AFTER FURTHER INSPECTION, NO OTHER PROBLEMS WERE FOUND.