BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE REVOLUTION

    MDR report key: 2912922 · Received December 19, 2012

    Report

    Report Number
    1718850-2012-01107
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    KFM
    PMA / PMN Number
    K011835
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE REVOLUTION CENTRIFUGAL PUMP HEAD. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A COMPLAINT REPORTING AN INABILITY TO ESTABLISH FLOW THROUGH THE REVOLUTION CENTRIFUGAL PUMP HEAD DURING A PROCEDURE. IT WAS ALSO REPORTED THAT THE PUMP HEAD WAS USED TO CIRCULATE PRIMING SOLUTION WITH NO ISSUES FOR 2 HOURS PRIOR TO STARTING THE PROCEDURE. THE PUMP HEAD WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY. THE PUMP HEAD HAS BEEN RETURNED FOR EVAL. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A COMPLAINT REPORTING AN INABILITY TO ESTABLISH FLOW THROUGH THE REVOLUTION CENTRIFUGAL PUMP HEAD DURING A PROCEDURE. IT WAS ALSO REPORTED THAT THE PUMP HEAD WAS USED TO CIRCULATE PRIMING SOLUTION WITH NO ISSUES FOR 2 HOURS PRIOR TO STARTING THE PROCEDURE. THE PUMP HEAD WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE REVOLUTION PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA NA 1207300061

    Patients

    Seq Age Sex Outcome Treatment
    1 NP