BEUDAMED
    FDA Adverse Event Summary report: N

    MCKAY DEE HSP OGDEN UT 1

    MDR report key: 5231871 · Received November 17, 2015

    Report

    Report Number
    1718850-2015-00454
    Date Received
    November 17, 2015
    Date of Event
    May 27, 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.

    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
    761004 MCKAY DEE HSP OGDEN UT 1 CUSTOM PERFUSION PACK KRJ SORIN GROUP USA N/A 1502600038

    Patients

    Seq Age Sex Outcome Treatment
    1