BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMO2X ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

    MDR report key: 3955645 · Received July 15, 2014

    Report

    Report Number
    1718850-2014-00230
    Event Type
    Other
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2018
    Report Date
    June 19, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K050447
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X ADULT HOLLOW FIBER MEMBRANE OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE BLOOD IN THE PRIMO2X OXYGENATOR WAS DARK AFTER GOING BACK ONTO BYPASS. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE BLOOD IN THE PRIMO2X OXYGENATOR WAS DARK AFTER GOING BACK ONTO BYPASS. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412942 PRIMO2X ADULT HOLLOW FIBER MEMBRANE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1312030023

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR