BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAG 250

    MDR report key: 6352842 · Received February 23, 2017

    Report

    Report Number
    3005290010-2017-00106
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Date of Event
    December 30, 2016
    Report Date
    February 22, 2017
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    LPZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THAWING OF A CRYOMACS FREEZING BAG 250 (CFB) THE CFB BROKE COMPLETELY. THE CUSTOMER STATED THAT THEY WERE ABLE TO TRANSPLANT THE PATIENT WITH SUFFICIENT CELLULAR MATERIAL AND THAT THE PATIENT SUCCESSFULLY ENGRAFTED. THEREFORE, ANY RISK FOR THE PATIENT COULD BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136213 CRYOMACS FREEZING BAG 250 CRYOMACS FREEZING BAG 250 LPZ MILTENYI BIOTEC GMBH N/A 6160205003

    Patients

    Seq Age Sex Outcome Treatment
    1