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 THAT A COMBI SET BLOOD LEAK OCCURRED APPROXIMATELY THIRTY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. A TECHNICIAN WAS PASSING BY THE PATIENT¿S STATION WHEN THEY NOTICED BLOOD ON THE BASE OF THEIR MACHINE. UPON FURTHER INSPECTION, THEY NOTICED A SLOW DRIP OF BLOOD LEAKING FROM THE CONNECTION OF THE HEPARIN LINE AND THE ARTERIAL BLOOD TUBING. IT WAS REPORTED THAT THE HEPARIN LINE HAD PARTIALLY SEPARATED. AFTER THE SOURCE OF THE LEAK WAS LOCATED, THE LINE WAS CLAMPED, THE BLOOD PUMP WAS STOPPED, AND THE PATIENT¿S BLOOD WAS MANUALLY RINSED BACK. REPORTEDLY, NOT ALL OF THE PATIENT¿S BLOOD COULD BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 80 ML. THE CM 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 PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE MACHINE, A FRESENIUS 2008T, DID NOT PRODUCE ANY ALARMS DURING THE EVENT. THE CM WAS UNSURE IF THERE WERE ANY CHANGES IN PRESSURE THAT MAY HAVE CAUSED THE SEPARATION AND LEAK. NO LEAKING WAS NOTICED DURING THE PRIMING OF THE LINES, AND NO DEFECTS WERE NOTED ON THE COMBI SET PRIOR TO USE. PER THE CM, THERE WERE NO ISSUES WITH ANY OTHER COMBI SETS FROM THIS LOT. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

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 THAT A COMBI SET BLOOD LEAK OCCURRED APPROXIMATELY THIRTY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. A TECHNICIAN WAS PASSING BY THE PATIENT¿S STATION WHEN THEY NOTICED BLOOD ON THE BASE OF THEIR MACHINE. UPON FURTHER INSPECTION, THEY NOTICED A SLOW DRIP OF BLOOD LEAKING FROM THE CONNECTION OF THE HEPARIN LINE AND THE ARTERIAL BLOOD TUBING. IT WAS REPORTED THAT THE HEPARIN LINE HAD PARTIALLY SEPARATED. AFTER THE SOURCE OF THE LEAK WAS LOCATED, THE LINE WAS CLAMPED, THE BLOOD PUMP WAS STOPPED, AND THE PATIENT¿S BLOOD WAS MANUALLY RINSED BACK. REPORTEDLY, NOT ALL OF THE PATIENT¿S BLOOD COULD BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 80 ML. THE CM 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 PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE MACHINE, A FRESENIUS 2008T, DID NOT PRODUCE ANY ALARMS DURING THE EVENT. THE CM WAS UNSURE IF THERE WERE ANY CHANGES IN PRESSURE THAT MAY HAVE CAUSED THE SEPARATION AND LEAK. NO LEAKING WAS NOTICED DURING THE PRIMING OF THE LINES, AND NO DEFECTS WERE NOTED ON THE COMBI SET PRIOR TO USE. PER THE CM, THERE WERE NO ISSUES WITH ANY OTHER COMBI SETS FROM THIS LOT. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.