MCKAY DEE HSP OGDEN UT 1

Additional Manufacturer Narrative

THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP RECEIVED A REPORT THAT DURING PRIMING, THE PRE-BYPASS FILTER OF THE CUSTOM PERFUSION PACK FAILED TO PRIME AND THE PRIMING FLUID WAS UNABLE TO PASS THROUGH THE FILTER. THERE WAS NO PATIENT INVOLVEMENT. A USER REPORT WAS FILED FOR THIS EVENT UNDER REPORT NUMBER (B)(4). THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. EVALUATION IS NOT COMPLETED.

Description of Event or Problem

SORIN GROUP RECEIVED A REPORT THAT DURING PRIMING, THE PRE-BYPASS FILTER OF THE CUSTOM PERFUSION PACK FAILED TO PRIME AND THE PRIMING FLUID WAS UNABLE TO PASS THROUGH THE FILTER. THERE WAS NO PATIENT INVOLVEMENT.