BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2972475 · Received February 15, 2013

    Report

    Report Number
    3002037047-2013-00009
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    S.A. ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF TWO COMPLAINTS REPORTED FOR THIS ISSUE. THERE HAVE BEEN NO ADD¿L COMPLAINTS REPORTED AGAINST THE FINISH GOODS LOT NUMBERS 1339538H OR 1345087H AND THE DEVICE HISTORY RECORD (DHR) SHOWS THAT THE PRODUCTS WERE RELEASED PER SPECIFICATIONS. A SAMPLE WAS NOT RETURNED TO THE MFR FOR ANALYSIS; HOWEVER, BASED ON THE CUSTOMER¿S REPORT THE DEVICES ¿ARE NO LONGER PACKED IN A CARTON BOX, BUT LOOSE IN A BAG. THE TUBING WAS CAUGHT BETWEEN THE CASSETTE AND THE BOTTLE, WHICH CAUSED THE TUBING TO BE KINKED¿. THE CUSTOMER IS REFERRING TO THE CHANGE TO A TRAYLESS PACKAGING CONFIGURATION; THE PREVIOUS VERSIONS OF THE DEVICE THAT THE CUSTOMER HAD RECEIVED WERE PLACED INSIDE OF A PLASTIC TRAY. WHILE THE CHANGE TO A TRAYLESS DEVICE CONFIGURATION MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER¿S REPORTED COMPLAINT, A ROOT CAUSE COULD NOT BE IDENTIFIED. THIS IS DUE TO THE FACT THAT OTHER FACTORS SUCH AS THE CUSTOM PAK¿S CONFIGURATION, ADD-AFTER PLACEMENT, OR SHIPPING DAMAGE COULD HAVE ALSO INFLUENCED THE TUBING TO BE BENT. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR THIS EVENT. AN ACTION HAS BEEN OPENED TO DETERMINE A ROOT CAUSE AND IMPLEMENT APPROPRIATE CORRECTIVE ACTION FOR COMPLAINTS OF A SIMILAR NATURE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT ON FOUR OCCASIONS THE INFUSION LINES OUT OF THEIR PAKS HAVE BEEN BENT. TWO OF THE FOUR INFUSION LINES WERE NOTED AS BENT PRIOR TO SURGERY THEREFORE WERE NOT USED. THE OTHER TWO LINES WERE USED DURING PROCEDURES AND RESULTED IN FLUIDICS IMBALANCES. THIS REPORT IS FOR THE TWO INFUSION LINES THAT WERE NOTED TO HAVE BEEN BENT PRIOR TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69527 CUSTOM PAK CONVENIENCE KIT KYG S.A. ALCON-COUVREUR N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INFINITI BASIC PAK| INFINITI VISION SYSTEM OZIL