BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTA ESSENTIAL CELL SEPARATOR

    MDR report key: 5060704 · Received September 1, 2015

    Report

    Report Number
    9611109-2015-00311
    Event Type
    Other
    Date Received
    September 1, 2015
    Date of Event
    May 19, 2015
    Report Date
    March 13, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE TESTED THE UNIT BUT WAS UNABLE TO REPRODUCE THE REPORTED MALFUNCTION. PREVENTIVE MAINTENANCE WAS PERFORMED WITHOUT MALFUNCTION AND THE DEVICE WAS RETURNED TO SERVICE. AS THE ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE WAS NOT DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. EVALUATED ON SITE BY LIVANOVA TECHNICIAN.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) IS THE MFR OF THE ELECTA ESSENTIAL CELL SEPARATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE ELECTA AUTOTRANSFUSION DEVICE DISPLAYED AN ERROR MESSAGE DURING SETUP. REBOOTING THE SYSTEM DID NOT CORRECT THE ERROR. THE SYSTEM WAS NOT USED. THERE WAS NO PT INJURY. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE ELECTA AUTOTRANSFUSION DEVICE DISPLAYED AN ERROR MESSAGE DURING SETUP. REBOOTING THE SYSTEM DID NOT CORRECT THE ERROR. THE SYSTEM WAS NOT USED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579921 ELECTA ESSENTIAL CELL SEPARATOR APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP DEUTSCHLAND 75210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR