BEUDAMED
    FDA Adverse Event Other Summary report: N

    XTRA AUTOTRANSFUSION SYSTEM

    MDR report key: 1942892 · Received December 20, 2010

    Report

    Report Number
    1718850-2010-00175
    Event Type
    Other
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K101586
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS REQUESTED BUT NOT PROVIDED BY THE FACILITY. A F/U REPORT WILL BE SENT IF THIS INFO IS RECEIVED. SORIN GROUP (B)(4) MANUFACTURES THE XTRA AUTOTRANSFUSION SYSTEM. THE INCIDENT OCCURRED AT (B)(6) HOSPITAL IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE PERFUSIONIST REPORTED THAT THE XTRA AUTOTRANSFUSION SYSTEM LOCK UPPED WHILE PROCESSING BLOOD. PRELIMINARY TESTING PERFORMED BY SORIN GROUP (B)(4) REVEALED A SOFTWARE PROBLEM THAT MAY CORRUPT CERTAIN PT RECORDS. A SYSTEM LOCK UP MAY OCCUR IF THE USER ATTEMPTS TO ACCESS A CORRUPT FILE. SORIN GROUP IS WORKING TO IDENTIFY A ROOT CAUSE AND DEVELOP A CORRECTIVE ACTION FOR THIS SOFTWARE ISSUE. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO HARM TO PT. THE PERFUSIONIST EXPRESSED A CONCERN THAT THIS TYPE OF ISSUE COULD LEAD TO ADD'L PROBLEMS FOR BY THE USER AND THEREFORE, COULD CAUSE "UNNECESSARY RISK TO PT SAFETY". THIS REPORT IS BEING FILED AS A RESULT OF THIS ALLEGATION.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT THE XTRA AUTOTRANSFUSION SYSTEM LOCK UPPED WHILE PROCESSING BLOOD. THE FAILURE DID NOT AFFECT THE MACHINE'S ABILITY TO PROCESS BLOOD AND THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTRA AUTOTRANSFUSION SYSTEM AUTOTRANSFUSION APPARATUS CAC SORIN GROUP ITALIA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1