COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

CORRECTION: D4. ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. ONE PHOTOGRAPH WAS PROVIDED. BASED ON THE PHOTOGRAPH, IT WAS CONFIRMED THAT THE PRODUCT LEAKED FROM THE TWISTER. 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. THE REPORTED EVENT WAS CONFIRMED BASED ON THE PROVIDED PHOTOGRAPH.

Description of Event or Problem

A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED FROM THE ACCESS DIAL IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. AFTER THE BLOODLINE WAS REMOVED IT WAS NOTED THAT THE ACCESS DIAL WOULD NOT TURN. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER: NOT AVAILABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

Description of Event or Problem

A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED FROM THE ACCESS DIAL IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. AFTER THE BLOODLINE WAS REMOVED IT WAS NOTED THAT THE ACCESS DIAL WOULD NOT TURN. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER: NOT AVAILABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

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