BEUDAMED
    FDA Adverse Event Other Summary report: N

    CP85315 IT MODENA

    MDR report key: 2925254 · Received January 14, 2013

    Report

    Report Number
    1718850-2012-01118
    Event Type
    Other
    Date Received
    January 14, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 18, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE CUSTOMER PERFUSION PACK. THE D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510(K) NUMBER OF THE EOS OXYGENATOR IS K043323. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING PRIMING, A LEAK WAS OBSERVED FROM THE HOUSING OF THE OXYGENATOR. THE UNIT WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. THE FACILITY REPORTED THIS INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING PRIMING, A LEAK WAS OBSERVED FORM THE HOUSING OF THE OXYGENATOR. THE UNIT WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20211 CP85315 IT MODENA CUSTOMER PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1205040162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA