BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRIUM

    MDR report key: 826373 · Received July 19, 2005

    Report

    Report Number
    1219977-2005-00005
    Event Type
    Other
    Date Received
    July 19, 2005
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO ATRIUM MEDICAL CORP, THEREFORE, A COMPLETE EVALUATION CAN NOT BE MADE. DUE TO THE INTRINSIC NATURE OF THE DEVICE, A SMALL NUMBER OF BLOOD BAGS WILL POP OPEN DURING STORAGE AND TRANSIT.

    Description of Event or Problem · 1

    EVENT DESC: SELF FILLING ATS BLOOD BAG - 700ML VOLUME - WAS SELF INFLATED PRIOR TO PT ATRIUM CONNECTION OR PT USE. TWO OTHERS WITH THE SAME LOT NUMBER WERE ALREADY INFLATED IN PACKAGE BEFORE USE. NO PT HARM. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM SELF FILLING ATS BLOOD BAG CAC ATRIUM MEDICAL CORP. 2450 10004475

    Patients

    Seq Age Sex Outcome Treatment
    1 *