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 REGISTERED NURSE (RN) /CLINICAL COORDINATOR (CC) FROM A USER FACILITY REPORTED THAT A COMBISET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE CC SAID AN AIR DETECTOR MESSAGE WENT OFF ABOUT ONE AND A HALF HOURS INTO THE TREATMENT. THE TECHNICIAN OPERATING THE MACHINE COULD NOT CLEAR THE ALARM, SO THEY DECIDED TO RETURN THE PATIENT¿S BLOOD AND RE-STRING THE MACHINE. AS THE PATIENT¿S BLOOD WAS BEING REINFUSED, THE TECHNICIAN NOTICED BLOOD ON THE MACHINE AND SAW THAT IT WAS COMING FROM THE HEPARIN LINE T-CONNECTOR, JUST BELOW THE BLOOD PUMP ON THE ARTERIAL SIDE. THE BLOOD WAS LEAKING FROM THE CONNECTION POINT OF THE MAIN LINE TO THE T-CONNECTOR. AS THE SUPPLIES WERE BEING REMOVED, THE MAIN LINE COMPLETELY SEPARATED FROM THE CONNECTOR. THE CC SAID THE PATIENT¿S BLOOD HAD ALREADY BEEN RETURNED AND BLOOD LOSS FROM THE LEAK WAS MINIMAL. ESTIMATED BLOOD LOSS (EBL) FROM THE LEAK WAS LESS THAN 5 ML. PRIOR TO THE LEAK, THERE WERE NO KNOWN LOOSE CONNECTIONS ON THE COMBISET LINES. THE CC SAID THERE WERE NO LEAKS NOTICED DURING THE PRIMING PHASE. IN ADDITION, THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE FAILURE. THE CC CONFIRMED THERE WAS NO PATIENT SERIOUS 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 THE SAME MACHINE. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR 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 REGISTERED NURSE (RN) /CLINICAL COORDINATOR (CC) FROM A USER FACILITY REPORTED THAT A COMBISET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE CC SAID AN AIR DETECTOR MESSAGE WENT OFF ABOUT ONE AND A HALF HOURS INTO THE TREATMENT. THE TECHNICIAN OPERATING THE MACHINE COULD NOT CLEAR THE ALARM, SO THEY DECIDED TO RETURN THE PATIENT¿S BLOOD AND RE-STRING THE MACHINE. AS THE PATIENT¿S BLOOD WAS BEING REINFUSED, THE TECHNICIAN NOTICED BLOOD ON THE MACHINE AND SAW THAT IT WAS COMING FROM THE HEPARIN LINE T-CONNECTOR, JUST BELOW THE BLOOD PUMP ON THE ARTERIAL SIDE. THE BLOOD WAS LEAKING FROM THE CONNECTION POINT OF THE MAIN LINE TO THE T-CONNECTOR. AS THE SUPPLIES WERE BEING REMOVED, THE MAIN LINE COMPLETELY SEPARATED FROM THE CONNECTOR. THE CC SAID THE PATIENT¿S BLOOD HAD ALREADY BEEN RETURNED AND BLOOD LOSS FROM THE LEAK WAS MINIMAL. ESTIMATED BLOOD LOSS (EBL) FROM THE LEAK WAS LESS THAN 5 ML. PRIOR TO THE LEAK, THERE WERE NO KNOWN LOOSE CONNECTIONS ON THE COMBISET LINES. THE CC SAID THERE WERE NO LEAKS NOTICED DURING THE PRIMING PHASE. IN ADDITION, THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE FAILURE. THE CC CONFIRMED THERE WAS NO PATIENT SERIOUS 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 THE SAME MACHINE. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.