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.

Additional Manufacturer Narrative

THIS INCIDENT OCCURED DURING PRIMING AND SO "NO PATIENT INVOLVEMENT" WAS INDICATED ON THE INITIAL REPORT, HOWEVER PATIENT INFORMATION HAS BEEN PROVIDED BY THE FACILITY: PT AGE: (B)(6) YEARS. DOB NOT PROVIDED. PT GENDER. FEMALE. PT WEIGHT. (B)(6).

Additional Manufacturer Narrative

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 4600040000-2015-8006. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION. TWO PRE-BYPASS FILTERS WERE RETURNED TO SORIN GROUP USA FOR FURTHER ANALYSIS. AN ADDITIONAL PRE-BYPASS FILTER FROM A DIFFERENT LOT (LOT 1513300043) WAS PULLED FROM INVENTORY TO BE USED AS A CONTROL. A VISUAL INSPECTION WAS CONDUCTED ON ALL THREE DEVICES AND NO DEFECTS WERE FOUND. A PRIMING TEST WAS ALSO CONDUCTED USING SALINE SOLUTION AND BOTH RETURNED DEVICES AND THE CONTROL UNIT WORKED AS EXPECTED AND DID NOT OCCLUDE FLOW. AN ADDITIONAL PRIMING TEST WAS CONDUCTED WITHOUT CORRECTLY LETTING ALL OF THE AIR OUT OF THE FILTER TO ATTEMPT TO SIMULATE THE REPORTED OCCLUSION, BUT THIS TEST ALSO WAS UNABLE TO CONFIRM THE ISSUE. WITHOUT THE ABILITY TO REPRODUCE THE ISSUE, A ROOT CAUSE COULD NOT BE DETERMINED. NO TREND HAS BEEN IDENTIFIED FOR THIS TYPE OF ISSUE. SORIN GROUP WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATING TO THIS ISSUE.