BEUDAMED
    FDA Adverse Event Other Summary report: N

    CP84050 FR LA REUNION

    MDR report key: 2585567 · Received May 17, 2012

    Report

    Report Number
    1718850-2012-00064
    Event Type
    Other
    Date Received
    May 17, 2012
    Date of Event
    March 27, 2012
    Report Date
    April 18, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K043323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THIS CUSTOM PERFUSION PACK. THE EOS OXYGENATOR IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE 510(K) NUMBER FOR THE EOS OXYGENATOR IS K043323. 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 THREE HOURS INTO A PROCEDURE, THE RESERVOIR FILTER BECAME CLOGGED RESULTING IN AN INABILITY TO MAINTAIN ADEQUATE FLOW. THERE WAS NO PT INJURY. THE PT'S BLOOD TEMPERATURE WAS DECREASED TO 18 DEGREE CELSIUS, THE DEVICE WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS. THE FACILITY HAS REPORTED THIS EVENT TO THE (B)(4). THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS ACTION. SORIN GROUP (B)(4) HAS REQUESTED THAT THE DEVICE BE RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WITH THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THREE HOURS INTO A PROCEDURE, THE RESERVOIR FILTER BECAME CLOGGED RESULTING IN AN INABILITY TO MAINTAIN ADEQUATE FLOW. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP84050 FR LA REUNION OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1104150096

    Patients

    Seq Age Sex Outcome Treatment
    1 NP