BEUDAMED
    FDA Adverse Event Summary report: N

    MCKAY DEE HSP OGDEN UT 1

    MDR report key: 5231867 · Received November 17, 2015

    Report

    Report Number
    1718850-2015-00453
    Date Received
    November 17, 2015
    Date of Event
    May 12, 2015
    Report Date
    October 5, 2015
    Manufacturer
    SORIN GROUP USA
    Product Code
    KRJ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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 · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760081 MCKAY DEE HSP OGDEN UT 1 CUSTOM PERFUSION PACK KRJ SORIN GROUP USA N/A 1502600038

    Patients

    Seq Age Sex Outcome Treatment
    1