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 PATIENT CARE TECHNICIAN (PCT) FROM A HEMODIALYSIS (HD) USER FACILITY REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HD TREATMENT. THE BLOOD LEAK OCCURRED WHEN THE FLOW LINE WAS REVERSED. IT WAS REPORTED THAT THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

Description of Event or Problem

ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE PCT WHO INITIALLY REPORTED THE EVENT. THE BLOOD LEAK OCCURRED APPROXIMATELY THIRTY MINUTES INTO HD TREATMENT. THE MACHINE PROMPTED THE OPERATOR TO TWIST THE LINES TO REVERSE THE FLOW, AND BLOOD STARTED LEAKING FROM THE TWISTER COMPONENT WHEN THE LINES WERE TWISTED. THE TUBING DID NOT DISCONNECT - IT REMAINED ATTACHED. THERE WERE NO VISIBLE DEFECTS AT OR NEAR THE LEAK LOCATION. THERE WERE NO MACHINE ALARMS THAT OCCURRED. THE PCT CONFIRMED THERE WERE NO CHANGES IN PRESSURE. ONCE THE LEAK WAS NOTICED, THE LINES WERE TWISTED BACK TO STOP THE LEAK. THE LEAKING STOPPED AND THE PATIENT'S BLOOD WAS ABLE TO BE RETURNED. THE PATIENT WAS DISCONNECTED AND RE-SETUP WITH NEW SUPPLIES. THE PATIENT COMPLETED THEIR TREATMENT ON THE SAME MACHINE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS <3 ML. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE SAMPLE 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

ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE PCT WHO INITIALLY REPORTED THE EVENT. THE BLOOD LEAK OCCURRED APPROXIMATELY THIRTY MINUTES INTO HD TREATMENT. THE MACHINE PROMPTED THE OPERATOR TO TWIST THE LINES TO REVERSE THE FLOW, AND BLOOD STARTED LEAKING FROM THE TWISTER COMPONENT WHEN THE LINES WERE TWISTED. THE TUBING DID NOT DISCONNECT - IT REMAINED ATTACHED. THERE WERE NO VISIBLE DEFECTS AT OR NEAR THE LEAK LOCATION. THERE WERE NO MACHINE ALARMS THAT OCCURRED. THE PCT CONFIRMED THERE WERE NO CHANGES IN PRESSURE. ONCE THE LEAK WAS NOTICED, THE LINES WERE TWISTED BACK TO STOP THE LEAK. THE LEAKING STOPPED AND THE PATIENT'S BLOOD WAS ABLE TO BE RETURNED. THE PATIENT WAS DISCONNECTED AND RE-SETUP WITH NEW SUPPLIES. THE PATIENT COMPLETED THEIR TREATMENT ON THE SAME MACHINE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS <3 ML. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.