CLIC BLOOD CHAMBER

Description of Event or Problem

IT WAS REPORTED THAT A CLIC BLOOD CHAMBER LEAKED BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS REPORTEDLY COMING FROM ¿THE JUNCTURE OF THE SMOOTH BLUE SECTION AND THE SQUARE BLUE/WHITE SECTION¿. THE SAMPLE WAS DISCARDED DUE TO CONCERNS OVER BLOOD EXPOSURE. IT IS UNKNOWN HOW MUCH BLOOD LOSS THERE WAS AS A RESULT OF THE REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL, AND THUS FAR, NO FURTHER DETAILS HAVE BEEN PROVIDED.

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

IT WAS REPORTED THAT A CLIC BLOOD CHAMBER LEAKED BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS REPORTEDLY COMING FROM ¿THE JUNCTURE OF THE SMOOTH BLUE SECTION AND THE SQUARE BLUE/WHITE SECTION¿. THE SAMPLE WAS DISCARDED DUE TO CONCERNS OVER BLOOD EXPOSURE. IT IS UNKNOWN HOW MUCH BLOOD LOSS THERE WAS AS A RESULT OF THE REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL, AND THUS FAR, NO FURTHER DETAILS HAVE BEEN PROVIDED.

Additional Manufacturer Narrative

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