BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAG 500

    MDR report key: 6199778 · Received December 22, 2016

    Report

    Report Number
    3005290010-2016-00101
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 22, 2016
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    LPZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ON A LEAKING TUBING OF A CRYOM&CS® FREEZING BAG 500 WHEN CELLULAR MATERIAL WAS FILLED IN THE BAG PRIOR TO FREEZING. TO MINIMIZE THE POSSIBILITY OF FURTHER CONTAMINATION, THE PRODUCT (73 ML OUT OF 360 ML) WAS IMMEDIATELY TRANSFERRED TO A NEW FREEZING BAG AND SUBJECTED TO AUTOMATED FREEZING PROCEDURE ACCORDINGLY. THE POSSIBLE IMPACT TO THE PATIENT INTENDED FOR STEM CELL TRANSPLANTATION IS CURRENTLY UNDER REVIEW ACCORDING TO THE CUSTOMER'S DESCRIPTION. THE CUSTOMER SENT PHOTOGRAPHS FOR A PRELIMINARY INVESTIGATION. THE AFFECTED FREEZING BAG WAS ALSO SENT TO MILTENYI BIOTEC (B)(4) BUT NOT YET ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849072 CRYOMACS FREEZING BAG 500 CRYOMACS FREEZING BAG 500 LPZ MILTENYI BIOTEC GMBH N/A 6160119004

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly