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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A HOLE WAS DISCOVERED IN THE COMBISET BLOODLINES DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. THE BIOMED PROVIDED ADDITIONAL INFORMATION DURING FOLLOW-UP. THE BIOMED STATED THAT BLOOD WAS OBSERVED COMING FROM A HOLE IN THE COMBISET BLOODLINES LOCATED NEAR THE BLOOD PUMP MODULE OF THE 2008T MACHINE APPROXIMATELY ONE MINUTE PRIOR TO THE COMPLETION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. TREATMENT WAS STOPPED AND THE PATIENT'S BLOOD WAS RETURNED. THE BIOMED STATED THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED ISSUE. THE BIOMED STATED THAT THERE WERE NO ISSUES ENCOUNTERED WITH THE COMBISET BLOODLINES PRIOR TO THE OCCURRENCE OF THIS ISSUE. ADDITIONALLY THERE WERE NO ISSUES IDENTIFIED WITH THE BLOOD PUMP OF THE 2008T MACHINE AND THE MACHINE HAS REMAINED IN SERVICE WITHOUT REOCCURRENCE OF THE REPORTED ISSUE. THE BIOMED STATED THAT THE COMPLAINT SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A HOLE WAS DISCOVERED IN THE COMBISET BLOODLINES DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. THE BIOMED PROVIDED ADDITIONAL INFORMATION DURING FOLLOW-UP. THE BIOMED STATED THAT BLOOD WAS OBSERVED COMING FROM A HOLE IN THE COMBISET BLOODLINES LOCATED NEAR THE BLOOD PUMP MODULE OF THE 2008T MACHINE APPROXIMATELY ONE MINUTE PRIOR TO THE COMPLETION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. TREATMENT WAS STOPPED AND THE PATIENT'S BLOOD WAS RETURNED. THE BIOMED STATED THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED ISSUE. THE BIOMED STATED THAT THERE WERE NO ISSUES ENCOUNTERED WITH THE COMBISET BLOODLINES PRIOR TO THE OCCURRENCE OF THIS ISSUE. ADDITIONALLY THERE WERE NO ISSUES IDENTIFIED WITH THE BLOOD PUMP OF THE 2008T MACHINE AND THE MACHINE HAS REMAINED IN SERVICE WITHOUT REOCCURRENCE OF THE REPORTED ISSUE. THE BIOMED STATED THAT THE COMPLAINT SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE MANUFACTURER DID NOT RECEIVE THE COMPLAINT PRODUCT SAMPLE FOR EVALUATION. HOWEVER, A PHOTO OF THE ALLEGED MALFUNCTION WAS RECEIVED. ON THE PHOTOGRAPH IT CAN BE OBSERVED THAT THE PUMP TUBING OF THE ARTERIAL LINE IS DAMAGED. A TEAR WAS FOUND IN THE PUMP TUBING. THE CAUSE OF THE TEAR IN THE PUMP TUBING COULD NOT BE ESTABLISHED SINCE THE SAMPLE WORKED AS INTENDED DURING THE WHOLE TREATMENT AND THE INCIDENT OCCURRED APPROXIMATELY ONE MINUTE BEFORE ENDING THE TREATMENT. HOWEVER, THIS KIND OF DAMAGE (TEAR) COULD BE CAUSED DUE TO AN INCORRECT HANDLING OF THE PRODUCT EITHER DURING THE MANUFACTURING PROCESS OR TREATMENT SET UP. THE ALLEGED FAILURE MODE WAS CONFIRMED WITH THE PHOTO RECEIVED. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE.