BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEXINGTON MEM W COLUMBIA SC 2

    MDR report key: 3464298 · Received October 30, 2013

    Report

    Report Number
    1718850-2013-00246
    Event Type
    Other
    Date Received
    October 30, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 3, 2013
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GISH ARTERIAL FILTER IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510(K) NUMBER OF THE ARTERIAL FILTER IS K914791. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING SET UP, THE ARTERIAL FILTER WAS FOUND TO HAVE BEEN ASSEMBLED BACKWARDS IN THE ARTERIAL LINE. THE PACK WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556133 LEXINGTON MEM W COLUMBIA SC 2 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 1310600054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA