COMBISET SMARTECH BLOODLINE

Additional Manufacturer Narrative

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 ACCOUNT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS COMBI SET 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

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A PATIENT¿S BLOOD COULD NOT BE RINSED BACK FROM THE SMARTECH COMBI SET ARTERIAL LINE AT THE END OF TREATMENT. IT IS UNKNOWN HOW MUCH BLOOD LOSS THIS RESULTED IN. THE BIOMED STATED THAT IT ACTS LIKE IT HAS A BACKFLOW PREVENTER. THE BIOMED STATED IT HAS HAPPENED MULTIPLE TIMES AT THIS CLINIC. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED AT INTAKE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) REVIEWS ARE STILL IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. AN SAP SHIPPING HISTORY SEARCH WAS PERFORMED TO IDENTIFY THE LOT NUMBERS THAT HAVE BEEN SHIPPED TO THIS ACCOUNT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. ACCORDING TO THE SAP SYSTEM, THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. 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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A PATIENT¿S BLOOD COULD NOT BE RINSED BACK FROM THE SMARTECH COMBI SET ARTERIAL LINE AT THE END OF TREATMENT. IT IS UNKNOWN HOW MUCH BLOOD LOSS THIS RESULTED IN. THE BIOMED STATED THAT IT ACTS LIKE IT HAS A BACKFLOW PREVENTER. THE BIOMED STATED IT HAS HAPPENED MULTIPLE TIMES AT THIS CLINIC. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED AT INTAKE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.