BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOSTORE CS500N

    MDR report key: 12561773 · Received September 30, 2021

    Report

    Report Number
    MW5104308
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 27, 2021
    Report Date
    September 28, 2021
    Manufacturer
    ORIGEN BIOMEDICAL, INC
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ORIGEN CRYOSTORE CS500N BAG WAS USED TO CRYOPRESERVE HPC, APHERESIS AUTOLOGOUS PRODUCT FOR A PATIENT. 100ML WAS CRYOPRESERVED IN THE BAG AND KEPT IN LIQUID NITROGEN VAPOR PHASE STORAGE. NO PROBLEMS WERE FOUND DURING CRYOPRESERVATION. THE BAG WAS THAWED AT THE PATIENT'S BEDSIDE. ONCE COMPLETELY THAWED, THE BAG WAS TURNED UPSIDE DOWN FOR INFUSION AND A LEAK WAS NOTICED FROM THE BAG. NO LEAK WAS SEEN DURING THAWING. A HOLE/BREAK BENEATH THE PORT WAS FOUND AS THE SOURCE FOR THE LEAK. THE PRODUCT WAS INFUSED WITH A SYRINGE TO PREVENT FURTHER LOSS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449527 CRYOSTORE CS500N CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS KSR ORIGEN BIOMEDICAL, INC CS500N W21779

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR