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.

Description of Event or Problem

A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE DISCONNECTED AT THE TWISTER CONNECTOR ONE AND A HALF HOURS AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY. FRESENIUS BLOODLINES WERE ALSO IN USE. THERE WERE NO ISSUES NOTED DURING PRIMING. THERE WERE NO CHANGES IN PRESSURE OF BLOOD FLOW RATE DURING THE TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT OPTED TO END TREATMENT TWO AND A HALF HOURS EARLY. THE PATIENT DID NOT HAVE ANY ISSUES AS A RESULT OF ENDING TREATMENT EARLY. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE DISCONNECTED AT THE TWISTER CONNECTOR ONE AND A HALF HOURS AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY. FRESENIUS BLOODLINES WERE ALSO IN USE. THERE WERE NO ISSUES NOTED DURING PRIMING. THERE WERE NO CHANGES IN PRESSURE OF BLOOD FLOW RATE DURING THE TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT OPTED TO END TREATMENT TWO AND A HALF HOURS EARLY. THE PATIENT DID NOT HAVE ANY ISSUES AS A RESULT OF ENDING TREATMENT EARLY. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.