COMBISET ACCESS FLOW REVERSE CON TWISTER

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.

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

IT WAS REPORTED THAT THE HEPARIN PUMP LINE DISCONNECTED FROM LINE SET AT INSERTION SITE DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT, INTERRUPTING TREATMENT. UPON FOLLOW-UP WITH THE CLINIC MANAGER (CM), IT WAS CONFIRMED THAT THE LEAK OCCURRED FROM THE PORT WHERE THE HEPARIN LINE CONNECTS TO THE REST OF THE BLOODLINE. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM AS THE LEAK WAS REPORTED TO BE AN EXTERNAL LEAK. THERE WERE NO LOOSE CONNECTIONS OR ISSUES NOTED DURING PRIMING. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 100 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISCARDED.