BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3031823 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08196
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHOTO OF THE SAMPLE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4): THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY NOR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.THE ACTUAL DEVICE WAS NOT AVAILABLE, HOWEVER A PICTURE HAS BEEN PROVIDED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION, BUT AN IMAGE OF THE AFFECTED SAMPLE WAS PROVIDED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE VISUAL EVALUATION OF THE PHOTOGRAPHIC SAMPLE DID NOT IDENTIFY ANY ISSUES. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER NEW ZEALAND THAT THERE WAS A DISCONNECTION AT THE TITANIUM ADAPTOR AND TRANSFER SET . THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134462 MINICAP TRANSFER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1