BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

    MDR report key: 7324407 · Received March 8, 2018

    Report

    Report Number
    1066733-2018-00005
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 2, 2018
    Report Date
    May 16, 2018
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE BAG WAS RETAINED BY THE USER AND SENT TO CHARTER MEDICAL, LTD. FOR INVESTIGATION. THE BAG WAS VISUALLY INSPECTED AND 2 ITEMS OF INTEREST WERE OBSERVED ON THE BAG AND FILM: AN ADHESIVE IDENTIFICATION LABEL WAS ATTACHED TO THE FRONT OF THE BAG. A FILM TEAR, APPROXIMATELY 1/4-INCH IN LENGTH, WAS OBSERVED APPROXIMATELY 1/4-INCH ABOVE THE TOP OF THE ADHESIVE LABEL. A FILM TEAR OF THE SIZE OBSERVED ON THE RETURNED SAMPLE WOULD HAVE LIKELY RESULTED IN A DETECTABLE LEAK DURING FILLING OF THE BAG. THE USER LABEL ATTACHED TO THE BAG MAY HAVE CONTRIBUTED TO THE BROKEN FILM THAT OCCURRED DURING THE THAWING PROCESS. AN ADHESIVE LABEL MAY HAVE INTERFERED WITH THE FLEXIBLE CHARACTERISTICS OF THE FILM, POSSIBLY RESULTING IN THE TEAR OBSERVED FROM THE BAG PROVIDED BY THE USER. THE ROOT CAUSE OF THE FILM CRACK ON THE BAG COULD NOT BE CONCLUSIVELY DETERMINED AND THE EXACT POINT IN THE PROCESS WHERE THE FILM CRACK OCCURRED IS UNKNOWN. THERE ARE OTHER POTENTIAL CAUSES THAT COULD RESULT IN A FILM CRACK OR TEAR: FILM DAMAGE INCURRED DURING HANDLING OF A FROZEN BAG. OVERFILLING THE BAG. AN OVERFILLED BAG COULD CREATE RESISTANCE DURING INSERTION AND REMOVAL OF THE BAG FROM THE METAL CASSETTE. MOISTURE ON THE EXTERIOR SURFACE OF THE BAG OR CASSETTE INTERIOR WHEN THE BAG IS INSERTED INTO THE METAL CASSETTE. MOISTURE MAY CAUSE THE BAG FILM TO FREEZE TO THE INTERIOR CASSETTE SURFACE, THUS POTENTIALLY RESULTING IN DAMAGE WHEN THE FROZEN BAG IS REMOVED FROM THE CASSETTE. THE PRODUCT INSTRUCTION FOR USE SHEET IS PROVIDED WITH EACH CF-250 DEVICE. REVIEW OF THE IFU VERSION PROVIDED WITH LOT 150920 HAS THE FOLLOWING PRECAUTIONS: "PORT TUBES AND FILM ARE FRAGILE IN THE FROZEN STATE AND BREAKAGE MAY OCCUR. HANDLE WITH CARE." "DO NOT ADHERE LABELS TO BAG SURFACE." "DO NOT OVERFILL." "ENSURE BAG EXTERIOR AND PROTECTIVE FREEZING CASSETTES ARE DRY PRIOR TO INITIATING FREEZING PROTOCOL. MOISTURE ON THE EXTERIOR OF THE BAG OR ON THE CASSETTE COULD CAUSE ADHERENCE OF THE BAG TO THE CASSETTE RESULTING IN DIFFICULTY OF BAG REMOVAL."

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE, OR PICTURES OF THE COMPLAINT DEVICE, WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/REVIEW. THE REPORTED LEAK DID NOT OCCUR DURING FILLING OF THE BAG, WHICH SUGGESTS THE LEAK LIKELY OCCURRED DURING HANDLING AFTER THE BAG WAS FROZEN. THERE WAS NO ADDITIONAL INFORMATION TO SUGGEST AN EXACT ROOT CAUSE FOR THIS REPORT. THERE ARE SEVERAL POTENTIAL ISSUES WHICH COULD CONTRIBUTE TO A FAILURE MODE OF THIS NATURE. RESIDUAL MOISTURE ON THE OUTSIDE OF THE BAG WHEN IT WAS PLACED INSIDE THE CASSETTE. RESIDUAL MOISTURE COULD CAUSE THE BAG TO FREEZE/ADHERE TO THE CASSETTE DURING THE FREEZING PROCESS. A CONDITION OF THIS TYPE COULD CAUSE FILM DAMAGE UPON REMOVAL OF A FROZEN BAG FROM THE CASSETTE. HANDLING OF THE BAG IN THE FROZEN STATE. THE FILM OF A FROZEN BAG IS FRAGILE - INADVERTENT MANIPULATION OR IMPACT ON THE BAG COULD CAUSE THE FILM TO FRACTURE. THE PRECAUTIONS INDICATED ABOVE ARE ADDRESSED IN THE PRODUCT IFU'S.

    Description of Event or Problem · 1

    THE CF-250 BAG, FROM LOT 150920 LEAKED WHILE PREPARING FOR INFUSION AT THE HOSPITAL. THE CELL MATERIAL INSIDE THE BAG WAS SALVAGED AND INFUSED INTO THE PATIENT. THERE WERE NO REPORTS OF AN ADVERSE EVENT, SERIOUS INJURY, OR DEATH AS A RESULT OF THIS OCCURRENCE. THERE WAS NO INFORMATION REGARDING ANY NEED FOR MEDICAL INTERVENTION AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167011 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER LPZ CHARTER MEDICAL, LTD. CF-250 150920

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR