BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO ELCTRA

    MDR report key: 3982889 · Received July 9, 2014

    Report

    Report Number
    1718850-2014-00208
    Event Type
    Other
    Date Received
    July 9, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(6) MANUFACTURES THE ELECTA WASH SET. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(6). SORIN GROUP (B)(6) RECEIVED A REPORT THAT AIR WAS PULLED INTO THE RE-INFUSION BAG OF THE WASH SET INSTEAD OF FLUID DURING AN AUTOTRANSFUSION PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(6) RECEIVED A REPORT THAT AIR WAS PULLED INTO THE RE-INFUSION BAG OF THE WASH SET INSTEAD OF FLUID DURING AN AUTOTRANSFUSION PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401741 DIDECO ELCTRA APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP ITALIA NA 1309260018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA