BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILTENYI CYOMACS FREEZING BAG 500

    MDR report key: 3634096 · Received February 11, 2014

    Report

    Report Number
    MW5034527
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 23, 2014
    Report Date
    February 10, 2014
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT INFUSION OF CRYOPRESERVED AUTOLOGOUS HPC, APHERESIS CELLULAR THERAPY PRODUCT (CTP) WAS SCHEDULED FOR (B)(6) 2014. AT TIME OF TRANSPLANT, BMT LAB TECHNOLOGISTS INSPECTED AND ISSUED THE CTP PER PROTOCOL IN PREPARATION FOR TRANSPLANT. BMT LAB TECHNOLOGISTS STATED THAT THE PHYSICAL INTEGRITY OF ALL FREEZE BAGS WAS INTACT UPON VISUAL EXAMINATION OF CTP PRODUCT AT TIME OF ISSUE OF CTP. CTP WAS TRANSPORTED TO PT BEDSIDE FOR THAWING AND INFUSION OF THAWED CELLS. UPON PERFORMING BEDSIDE VERIFICATION OF FREEZE BAG INTEGRITY AND LABELING IN PREPARATION FOR PRODUCT THAW, BMT LAB TECH STATED THEY OBSERVED A SMALL LINE ON THE SURFACE OF THE FREEZE BAG WITH UNIQUE ID (B)(4). UPON FURTHER INSPECTION OF THE FREEZE BAG, IT WAS DETERMINED THAT THE OBSERVED LINE ON THE FREEZE BAG SURFACE WAS ACTUALLY A FRACTURE EXTENDING THE ENTIRE VERTICAL LENGTH OF THE BAG FROM THE BASE OF THE BAG TO JUST UNDER THE OUTER MOST PORT OF THE TOP OF THE BAG. THE BMT LAB TECHNOLOGIST IN COLLABORATION WITH THE CLINICAL NURSE INFUSIONIST NOTIFIED THE ATTENDING PHYSICIAN OF THE OBSERVATION OF THE FRACTURED FREEZE BAG. IT WAS DETERMINED NOT TO INFUSE THE CELLS CONTAINED IN THE DAMAGED FREEZE BAG DUE TO THE NATURE AND EXTENT OF THE FRACTURE OF THE FREEZE BAG. THE PHYSICIAN DIRECTED THE BMT LAB TECHNOLOGIST TO RETURN THE FRACTURED FREEZE BAG TO THE LAB AND TO ISSUE AN ADDITIONAL/SUBSTITUTE PRODUCT BAG FOR INFUSION TO REPLACE THE DAMAGED PRODUCT. FREEZE BAG WITH UNIQUE ID (B)(4) WAS ISSUED AND INFUSED. THE INFUSED CD34+ DOSE MET THE MINIMUM CRITERIA OF 2.0 X 10 TO THE POWER OF 6/KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91163 MILTENYI CYOMACS FREEZING BAG 500 CRYOPRESERVATION/FREEZE BAG KSR MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 500 6120816006

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR