COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AS THE SAMPLE WAS NOT USED, DISINFECTION WAS NOT NEEDED. THE COMPANION PRODUCT SAMPLE WAS VISUALLY INSPECTED. DURING THE VISUAL INSPECTION, IT WAS CONFIRMED THAT THE MINI CLAMP IN THE 12¿ ARTERIAL MONITORING LINE WAS MISSING. AFTER FURTHER INSPECTION, NO OTHER ISSUES WERE FOUND. THIS KIND OF MISASSEMBLED COULD BE CAUSED DUE TO AN INCORRECT ASSEMBLY DURING THE MANUFACTURING PROCESS: INCORRECT ASSEMBLY TECHNIQUE UNQUALIFIED OPERATOR UNCLEAR WORK INSTRUCTION A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED BY THE MANUFACTURER. THERE WAS NO INDICATION OF PRODUCT NONACCEPTANCE, DEVIATION, NON-CONFORMANCE, REWORK, LABELING OR PROCESS CONTROL FAILURE DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE LOT MET ALL RELEASE CRITERIA. THE INVESTIGATION INTO THE COMPLAINT WAS ABLE TO CONFIRM THE REPORTED EVENT.

Description of Event or Problem

A USER FACILITY CHARGE NURSE (CN) REPORTED WHILE A HEMODIALYSIS (HD) PATIENT WAS ON TREATMENT, A TECHNICIAN APPROACHED THE MACHINE TO REVERSE THE LINES AFTER ACCESS FLOW WAS COMPLETED. BLOOD WAS NOTED LEAKING FROM THE TWISTER DEVICE. BLOOD PUMP WAS STOPPED AND WAS NOT RETURNED. TREATMENT WAS INTERRUPTED WITH BLOOD LOSS >100ML. UPON FOLLOW-UP, THE CN STATED A BLOOD LEAK OCCURRED FROM THE WHITE TWISTER PORT CONNECTED TO THE VENOUS LINE APPROXIMATELY FORTY MINUTES AFTER INITIATION OF TREATMENT. THE MACHINE, A 2008T, ALARMED WITH AN AN ARTERIAL BLOOD LEAK ALERT. PER CN IT WAS UNKNOWN WHAT CAUSED THE TWISTER PORT TO LEAK. A FRESENIUS 2008T HEMODIALYSIS MACHINE AND FRESENIUS 160NRE DIALYZER WERE BEING USED DURING THE INCIDENT. BLOOD TEST STRIPS WERE NOT REQUIRED OR USED. THE PATIENT'S BLOOD WAS RETURNED FROM THE ARTERIAL SIDE OF THE SET AND THE ESTIMATED BLOOD LOSS (EBL) WAS 100ML. IMMEDIATELY FOLLOWING THE EVENT, THE TREATMENT WAS HALTED AND THE PATIENT WAS RE-SETUP WITH A NEW DIALYZER AND BLOODLINES, AND COMPLETED THEIR TREATMENT ON A DIFFERENT MACHINE. THE CN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE COMBISET WAS AVAILABLE TO BE RETURNED 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 WHILE A HEMODIALYSIS (HD) PATIENT WAS ON TREATMENT, A TECHNICIAN APPROACHED THE MACHINE TO REVERSE THE LINES AFTER ACCESS FLOW WAS COMPLETED. BLOOD WAS NOTED LEAKING FROM THE TWISTER DEVICE. BLOOD PUMP WAS STOPPED AND WAS NOT RETURNED. TREATMENT WAS INTERRUPTED WITH BLOOD LOSS >100ML. UPON FOLLOW-UP, THE CN STATED A BLOOD LEAK OCCURRED FROM THE WHITE TWISTER PORT CONNECTED TO THE VENOUS LINE APPROXIMATELY FORTY MINUTES AFTER INITIATION OF TREATMENT. THE MACHINE, A 2008T, ALARMED WITH AN ARTERIAL BLOOD LEAK ALERT. PER CN IT WAS UNKNOWN WHAT CAUSED THE TWISTER PORT TO LEAK. A FRESENIUS 2008T HEMODIALYSIS MACHINE AND FRESENIUS 160NRE DIALYZER WERE BEING USED DURING THE INCIDENT. BLOOD TEST STRIPS WERE NOT REQUIRED OR USED. THE PATIENT'S BLOOD WAS RETURNED FROM THE ARTERIAL SIDE OF THE SET AND THE ESTIMATED BLOOD LOSS (EBL) WAS 100ML. IMMEDIATELY FOLLOWING THE EVENT, THE TREATMENT WAS HALTED AND THE PATIENT WAS RE-SETUP WITH A NEW DIALYZER AND BLOODLINES AND COMPLETED THEIR TREATMENT ON A DIFFERENT MACHINE. THE CN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE COMBISET WAS AVAILABLE TO BE RETURNED FOR EVALUATION.