COMBISET ACCESS FLOW REVERSE CON TWISTER

Description of Event or Problem

A USER FACILITY PATIENT CARE TECHNICIAN (PCT) REPORTED TO FRESENIUS THAT THE HEPARIN INFUSION LINE DISCONNECTED FROM ITS CONNECTION POINT ON THE COMBISET BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP WITH THE CHARGE NURSE AND ADDITIONAL INFORMATION WAS PROVIDED. THE CHARGE NURSE STATED THAT WITHIN THE FIRST FIVE MINUTES OF THE PATIENT¿S TREATMENT THAT THE PATIENT CARE TECHNICIAN (PCT) VISUALLY OBSERVED A DROP OF BLOOD ON THE MACHINE. THE DROP WAS WIPED AWAY AND ANOTHER DROP APPEARED ON THE FLOOR. THE PCT BELIEVED THE LEAK TO BE COMING FROM THE END OF THE HEPARIN LINE AND CLAMPED IT. THE CHARGE NURSE AND PCT BELIEVE THE WEIGHT OF THE CLAMP MAY HAVE DISCONNECTED THE HEPARIN LINE FROM THE REST OF THE COMBISET. UPON CLOSER INSPECTION IT APPEARED THE LEAK CAME FROM THE CONNECTION POINT BETWEEN THE HEPARIN LINE AND THE REST OF THE COMBISET. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME 2008T 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.

Description of Event or Problem

A USER FACILITY PATIENT CARE TECHNICIAN (PCT) REPORTED TO FRESENIUS THAT THE HEPARIN INFUSION LINE DISCONNECTED FROM ITS CONNECTION POINT ON THE COMBISET BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP WITH THE CHARGE NURSE AND ADDITIONAL INFORMATION WAS PROVIDED. THE CHARGE NURSE STATED THAT WITHIN THE FIRST FIVE MINUTES OF THE PATIENT¿S TREATMENT THAT THE PATIENT CARE TECHNICIAN (PCT) VISUALLY OBSERVED A DROP OF BLOOD ON THE MACHINE. THE DROP WAS WIPED AWAY AND ANOTHER DROP APPEARED ON THE FLOOR. THE PCT BELIEVED THE LEAK TO BE COMING FROM THE END OF THE HEPARIN LINE AND CLAMPED IT. THE CHARGE NURSE AND PCT BELIEVE THE WEIGHT OF THE CLAMP MAY HAVE DISCONNECTED THE HEPARIN LINE FROM THE REST OF THE COMBISET. UPON CLOSER INSPECTION IT APPEARED THE LEAK CAME FROM THE CONNECTION POINT BETWEEN THE HEPARIN LINE AND THE REST OF THE COMBISET. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME 2008T 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.