BEUDAMED
    FDA Adverse Event Other Summary report: N

    D 903 AVANT 2 PH I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING

    MDR report key: 3249371 · Received July 15, 2013

    Report

    Report Number
    1718850-2013-00122
    Event Type
    Other
    Date Received
    July 15, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K033323
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED. BECAUSE THE LOT NUMBER WAS NOT PROVIDED, THE EXPIRATION DATE IS UNK. SORIN GROUP (B)(4) MANUFACTURES THE D903 AVANT ADULT HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THIS ISSUE WAS REPORTED TO THE COUNTRY'S LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF INADEQUATE FLOW THROUGH THE D903 AVANT ADULT HOLLOW FIBER OXYGENATOR DURING A PROCEDURE. THE CIRCUIT WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327572 D 903 AVANT 2 PH I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING OXYGENATOR, CARDIOPULMONARY DTZ SORIN GROUP ITALIA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP