COMBISET ACCESS FLOW REVERSE CON TWISTER

Description of Event or Problem

A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS BLOODLINE HAD A CRACK IN IT DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. A FRESENIUS DIALYZER WAS ALSO IN USE. THE LEAK WAS NOTED TO ORIGINATE AT THE TWISTER LINE JUNCTION. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. NO ISSUES WERE NOTED DURING PRIMING. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AS THE COMPLAINT PRODUCT SAMPLE WAS DISINFECTED AND PREPARED FOR ANALYSIS, A LEAK WAS FOUND DUE TO A SEPARATION IN THE ARTERIAL MAIN LINE ASSEMBLED TO THE TWISTER. THE COMPLAINT PRODUCT SAMPLE WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THAT THE ARTERIAL TWISTER PORT ASSEMBLED TO THE ARTERIAL MAIN LINE WAS BROKEN. AFTER FURTHER INSPECTION, NO OTHER PROBLEMS WERE FOUND. 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. 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. UPON COMPLETION OF THE EVALUATION, THE REPORTED EVENT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS BLOODLINE HAD A CRACK IN IT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. A FRESENIUS DIALYZER WAS ALSO IN USE. THE LEAK WAS NOTED TO ORIGINATE AT THE TWISTER LINE JUNCTION. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. NO ISSUES WERE NOTED DURING PRIMING. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.