BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAG 500

    MDR report key: 8046239 · Received November 6, 2018

    Report

    Report Number
    MW5081124
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    August 22, 2018
    Report Date
    November 2, 2018
    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

    BMT LAB TECHNOLOGIST PERFORMED CELL PROCESSING PROCEDURE FOR AN AUTOLOGOUS HPC, APHERESIS CELLULAR THERAPY PRODUCT (CTP) WITH UNIQUE ID (B)(4) ON (B)(6) 2018 IN PREPARATION FOR CRYOPRESERVATION AND LONG TERM LN2 VAPOR PHASE STORAGE OF THE PRODUCT. THE TECHNOLOGIST DISPENSED ALL COMPONENTS OF THE CRYOPRESERVATION SOLUTION INTO THE CRYO BAG WITHOUT INCIDENT. DURING THE FINAL STEP OF THE PROCESSING PROCEDURE WHEN DISPENSING THE CTP ALIQUOT INTO THE CRO BAG CONTAINING THE CRYOPRESERVATION SOLUTION, THE TECHNOLOGIST OBSERVED A SMALL AMOUNT OF LEAKAGE OF THE CRYO BAG CONTENTS. VISUAL OBSERVATION OF THE CROY BAG TO LOCATE THE SOURCE OF THE LEAK REVEALED AN INTEGRITY FAILURE OF A VERY SMALL NICK IN THE CRYO BAG MATERIAL LOCATED AT THE BASE OF THE BAG JUST ABOVE THE BOTTOM SEAM WELD. THE BMT LAB TECHNOLOGIST IMMEDIATELY INITIATED CELL PRODUCT RESCUE MEASURES CLAMPING OFF THE AFFECTED AREA OF THE CRYO BAG TO PREVENT ADD'L LEAKAGE OF THE PRODUCT AND WORKED QUICKLY TO TRANSFER THE PRODUCT TO A NEW INTACT CRYO BAG. THE PRODUCT WAS SUBSEQUENTLY CRYOPRESERVED AND STORED IN LN2 VAPOR PHASE STORAGE WITHOUT INCIDENT. THE CELL LOSS RESULTING FROM THE LEAKAGE WAS DETERMINED TO BE MINIMAL, HOWEVER THE PRODUCT WAS SAMPLED FOR STERILITY AFTER TRANSFER OF THE PRODUCT TO THE SECONDARY BAG. STERILITY TESTING WAS RESULTED AS "NO GROWTH 14 DAYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884891 CRYOMACS FREEZING BAG 500 CONTAINER, EMPTY, FOR COLLECTION AND PROCESSING OF BLOOD AND BLOOD COMPONENTS KSR MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 500 6170615001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other