BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMO2X OXYGENATOR/SYSTEM

    MDR report key: 2930962 · Received January 14, 2013

    Report

    Report Number
    1718850-2012-01119
    Event Type
    Other
    Date Received
    January 14, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K050447
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF THE SORIN GROUP (B)(4). SORIN GROUP REC'D A REPORT THAT DURING THE BYPASS THE OPERATOR WAS UNABLE TO ACHIEVE SUCTION THROUGH THE ASPIRATION PORT OF THE OXYGENATOR. THE UNIT WAS CHANGED OUT IN ORDER TO CONTINUE WITH THE CASE. THERE WAS NO REPORT OF PT INJURY. IT WAS ALSO REPORTED THAT THE CHANGE OUT TOOK 10 MINS. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THE EXTENDED INTERRUPTION OF BYPASS. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP REC'D A REPORT THAT DURING THE BYPASS, THE OPERATOR WAS UNABLE TO ACHIEVE SUCTION THROUGH THE ASPIRATION PORT OF THE OXYGENATOR. THE UNIT WAS CHANGED OUT IN ORDER TO CONTINUE WITH THE CASE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20919 PRIMO2X OXYGENATOR/SYSTEM OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1208010036

    Patients

    Seq Age Sex Outcome Treatment
    1 NP