COMBISET SMARTECH BLOODLINE (NO HEPARIN)

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT THE INTEGRATED CRIT-LINE CLIP (CLIC) DEVICE ON THE COMBISET SMARTECH BLOODLINES SPLIT ON THE ARTERIAL LINE DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. FOLLOW-UP WAS CONDUCTED WITH THE USER FACILITY CHARGE NURSE. ADDITIONAL INFORMATION WAS LIMITED AS THEY WERE NOT PRESENT FOR THE REPORTED EVENT. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION REGARDING THE REPORTED ISSUE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 300 ML. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

CORRECTION: H10 (PLANT INVESTIGATION) PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE CUSTOMER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS COMBISET BLOODLINES SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. 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. A REVIEW OF THE DHR 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

IT WAS REPORTED TO FRESENIUS THAT THE INTEGRATED CRIT-LINE CLIP (CLIC) DEVICE ON THE COMBISET SMARTECH BLOODLINES SPLIT ON THE ARTERIAL LINE DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. FOLLOW-UP WAS CONDUCTED WITH THE USER FACILTY CHARGE NURSE. ADDITIONAL INFORMATION WAS LIMITED AS THEY WERE NOT PRESENT FOR THE REPORTED EVENT. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION REGARDING THE REPORTED ISSUE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 300 ML. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT THE INTEGRATED CRIT-LINE CLIP (CLIC) DEVICE ON THE COMBISET SMARTECH BLOODLINES SPLIT ON THE ARTERIAL LINE DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. FOLLOW-UP WAS CONDUCTED WITH THE USER FACILTY CHARGE NURSE. ADDITIONAL INFORMATION WAS LIMITED AS THEY WERE NOT PRESENT FOR THE REPORTED EVENT. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION REGARDING THE REPORTED ISSUE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 300 ML. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

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.