BEUDAMED
    FDA Adverse Event Other Summary report: N

    C21512 RU NOVOSIBIRSK

    MDR report key: 3240238 · Received July 17, 2013

    Report

    Report Number
    1718850-2013-00124
    Event Type
    Other
    Date Received
    July 17, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K953835
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CUSTOMER PERFUSION PACK. THE D901 LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR IS A COMPONENT OF THE PACK. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). IT WAS REPORTED THAT THE CHANGE OUT TOOK LONGER THAN 3 MINUTES. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THE EXTENDED INTERRUPTION OF BYPASS. 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 A BLOOD LEAK FROM THE LILLIPUT HOLLOW FIBER OXYGENATOR DURING A PROCEDURE. THE UNIT WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332522 C21512 RU NOVOSIBIRSK CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1104280066

    Patients

    Seq Age Sex Outcome Treatment
    1 NP