BERLIN HEART EXCOR DRIVING TUBE

Additional Manufacturer Narrative

EXEMPTION NUMBER: (B)(4). (B)(4) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART (B)(4) (MFR). THE EXCOR DRIVING TUBE LOT 00002867 WAS IN USE FROM (B)(6) 2012 UNTIL ITS REPLACEMENT (DATE UNK). THE DISTRIBUTOR RETURNED IT TO THE MFR WITHOUT EXPLANATION ON (B)(6) 2013. MULTIPLE PHONE CALLS FROM (B)(6) 2013 TO THE DISTRIBUTOR DETERMINED THE DRIVE LINE WAS RETURNED TO THE DISTRIBUTOR WITH A COMPLAINT OF AN AIR LEAK. IN THE INVESTIGATION A LEAK IN THE PASSAGE FROM THINNER TO THICKER DIAMETER WAS DETECTED. IT WAS REPORTED THAT THE PT WAS VERY ACTIVE. THEREFORE IT IS VERY LIKELY THAT THE LEAKAGE WAS CAUSED BY EXTERNAL FORCES DURING THE TIME OF USAGE. IN THE END IT IS NOT POSSIBLE TO FIND DEFINITELY THE ORIGIN OF THE INITIAL DAMAGE. (B)(4).

Description of Event or Problem

WE WERE INFORMED THAT THE HOSPITAL REPLACED A RED EXCOR DRIVING TUBE BECAUSE OF A LEAKAGE OF THE TUBE. WHEN THE INCIDENT OCCURRED THE PT WAS SUPPORTED WITH THE EXCOR STATIONARY DRIVING UNIT IKUS. WE WERE INFORMED THAT THERE WERE NO COMPLICATIONS REGARDING THE LEAKAGE OF THE EXCOR DRIVING TUBE OR AFTER THE REPLACEMENT. THE PT IS STILL SUPPORTED WITH THE EXCOR SYSTEM.