BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTITUTE DE CARDIOLOGIE 1

    MDR report key: 2614347 · Received June 5, 2012

    Report

    Report Number
    1718850-2012-00679
    Event Type
    Other
    Date Received
    June 5, 2012
    Date of Event
    May 4, 2012
    Report Date
    May 6, 2012
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT SEX WAS NOT PROVIDED. SORIN GROUP USA RECEIVED A REPORT THAT DURING SETUP, THE VENOUS LINE WAS FOUND TO BE KINKED. THE CLINICIAN ELECTED TO USE THE HEART LUNG PACK FOR THE PROCEDURE. DURING THE PROCEDURE, THE TUBING BECAME OCCLUDED, RESULTING IN A LOSS OF VENOUS RETURN AND DISTENSION OF THE HEART. THE TUBING WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT ANY FURTHER ISSUES. NO COMPLICATIONS TO THE PT OCCURRED DUE TO THE INCIDENT. THE PRODUCT WAS DISCARDED BY THE HOSPITAL. WITHOUT THE PRODUCT FOR EVALUATION SORIN GROUP USA WAS UNABLE TO CONFIRM THE DEFECT OR DETERMINE ROOT CAUSE. THE HEART LUNG PACK INSTRUCTIONS FOR USE STATE "VISUALLY INSPECT THE PACK FOR ANY OBVIOUS DEFECTS IN MATERIALS OR ASSEMBLY". NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT DURING SETUP, THE VENOUS LINE WAS FOUND TO BE KINKED. THE CLINICIAN ELECTED TO USER THE HEART LUNG PACK FOR THE PROCEDURE. DURING THE PROCEDURE, THE TUBING BECAME OCCLUDED, RESULTING IN A LOSS OF VENOUS RETURN AND DISTENSION OF THE HEART. THE TUBING WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT ANY FURTHER ISSUES. NO COMPLICATIONS TO THE PT OCCURRED DUE TO THE INCIDENT. THE PRODUCT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTITUTE DE CARDIOLOGIE 1 CUSTOM PERFUSION PACK DWF SORIN GROUP USA, INC. NA 1203100050

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other