BEUDAMED
    FDA Adverse Event Other Summary report: N

    D100 DIDECO KIDS

    MDR report key: 2092950 · Received May 11, 2011

    Report

    Report Number
    1718850-2011-00051
    Event Type
    Other
    Date Received
    May 11, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 11, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K061031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D100 KIDS OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE MEDICAL STAFF DECIDED TO CHANGE OUT THE OXYGENATOR DUE TO CLOTTING IN THE RESERVOIR. DURING THE CHANGE OUT, THE PT WAS SUSTAINED WITH DRUGS. THERE WAS NO REPORT OF PT INJURY. THE PRODUCT HAS BEEN RETURNED TO SORIN GROUP (B)(4). THE INVESTIGATION IS ON-GOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO REPORT OF PT INJURY AS A RESULT OF THIS ISSUE. THE PT WAS SUSTAINED WITH DRUGS AND THE FACILITY REPORTED THE INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH IS BEING FILED AS A RESULT OF THESE ACTIONS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE PROCEDURE, CLOTTING WAS SEEN IN THE RESERVOIR. THE UNIT WAS CHANGED OUT. DURING THE CHANGE OUT, THE PT WAS SUSTAINED WITH DRUGS. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D100 DIDECO KIDS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1102010068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention