BEUDAMED
    FDA Adverse Event Other Summary report: N

    SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

    MDR report key: 3651405 · Received February 20, 2014

    Report

    Report Number
    1718850-2014-00038
    Event Type
    Other
    Date Received
    February 20, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 27, 2014
    Manufacturer
    SORIL GROUP ITALIA
    Product Code
    DTN
    PMA / PMN Number
    K092315
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE VVR4000I SMARXT HP N/S. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING PACKAGE OPENING, IT WAS FOUND THE VENOUS RETURN PORT HAD BROKEN OFF OF THE VENOUS HARDSHELL RESERVOIR. THE UNIT WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106366 SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIL GROUP ITALIA NA 1307150088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA