BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHILDRENS HSP NEW ORLEANS LA 1

    MDR report key: 3982843 · Received July 9, 2014

    Report

    Report Number
    1718850-2014-00224
    Event Type
    Other
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED CARDIOPLEGIA LINE WAS RETURNED TO SORIN GROUP FOR EVALUATION. 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 THERE SEEMED TO BE AIR BEING PULLED IN FROM ONE OF THE CONNECTORS OF THE CARDIOPLEGIA LINE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401806 CHILDRENS HSP NEW ORLEANS LA 1 CUSTOM PERFUSION PACK DTL SORIN GROUP USA, INC. NA 1317000027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA