BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIDECO PERFUSION TUBING SYSTEM - ES SANTANDER

    MDR report key: 1491824 · Received October 2, 2009

    Report

    Report Number
    1718850-2009-00047
    Event Type
    Death
    Date Received
    October 2, 2009
    Date of Event
    August 30, 2009
    Report Date
    September 4, 2009
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL DID NOT PROVIDE THE PT IDENTIFIER NUMBER OR THE WEIGHT OF THE PT. THE AVANT IS MANUFACTURED BY SORIN GROUP. THE CUSTOMER PERFUSION PACK, CATALOG NUMBER 085279, IS A PREAMENDMENT DEVICE. THE INCIDENT OCCURRED IN SPAIN. THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP. THE REPORT STATED THAT AT THE END OF A TRANSPLANT PROCEDURE, AIR WAS SEEN IN THE ARTERIAL LINE. THE PT EXPIRED. THE PERFUSIONIST STATED THAT THE MEDICAL DEVICE DID NOT CONTRIBUTE TO THE INCIDENT. THE HOSPITAL HAS STATED THAT THE UNIT WILL NOT BE RETURNED FOR EVALUATION. WITHOUT THE PRODUCT FOR EVALUATION, THE CAUSE OF THE INCIDENT CANNOT BE DETERMINED OR CONFIRMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION OR THE DEVICE IS MADE AVAILABLE.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT AT THE END OF A TRANSPLANT PROCEDURE, AIR WAS SEEN IN THE ARTERIAL LINE. THE PT EXPIRED. THE PERFUSIONIST STATED THAT THE MEDICAL DEVICE DID NOT CONTRIBUTE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIDECO PERFUSION TUBING SYSTEM - ES SANTANDER CUSTOM PERFUSION PACK DWE SORIN GROUP ITALIA S.R.L. NA 0903170094

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death