BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

    MDR report key: 6631080 · Received June 9, 2017

    Report

    Report Number
    1066733-2017-00007
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    April 20, 2017
    Report Date
    June 8, 2017
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK060042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. THE ROOT CAUSE OF THE FILM CRACK COULD NOT BE CONCLUSIVELY DETERMINED AND THE EXACT POINT IN THE PROCESS WHERE THE FILM CRACK OCCURRED IS UNKNOWN. THERE ARE OTHER CAUSES THAT COULD POTENTIALLY RESULT IN A FILM CRACK OR TEAR: FILM DAMAGE INCURRED DURING HANDLING OF A FROZEN BAG. A LABEL ATTACHED TO THE BAG SURFACE COULD INTERFERE WITH THE FLEXIBILITY OF THE FILM DURING CRYOGENIC FREEZING AND THAWING PROCESSES. OVERFILLING THE BAG. AN OVERFILLED BAG COULD CREATE RESISTANCE DURING INSERTION AND REMOVAL OF THE BAG FROM THE METAL CASSETTE. EXCESSIVE AIR LEFT INSIDE THE BAG AFTER FILLING, RESULTING IN RAPID EXPANSION DURING THAWING. 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. ALTHOUGH THERE WAS NO EVIDENCE, THERE IS ALWAYS THE POSSIBILITY THAT AN UNDETECTED MATERIAL ISSUE COULD CONTRIBUTE TO A TEAR OF THIS NATURE. THE PRODUCT INSTRUCTION FOR USE SHEET IS PROVIDED WITH EACH CML-75LN DEVICE. REVIEW OF THE IFU VERSION PROVIDED WITH LOT 142707 HAS THE FOLLOWING PRECAUTIONS: "DO NOT WRITE ON BAG SURFACE, BACK SIDE OF LABEL OR ADHERE LABELS TO BAG SURFACE." "AFTER FREEZING, DO NOT HANDLE EXCESSIVELY. PORT TUBES AND FILM ARE FRAGILE IN THE FROZEN STATE AND BREAKAGE MAY OCCUR. HANDLE WITH CARE." "DO NOT OVERFILL." "REMOVE AS MUCH AIR AS POSSIBLE FROM THE CONTAINER." "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." SAMPLE NOT RETURNED TO CHARTER MEDICAL.

    Description of Event or Problem · 1

    THE BAG BREAK WAS DISCOVERED DURING THE THAWING PROCESS WHILE THE CELL MATERIAL WAS BEING PROCESSED. THERE WAS NO CONTACT WITH A PATIENT WHEN THE LEAK OCCURRED. THERE WAS NO INJURY, DEATH OR FURTHER MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS OCCURRENCE. THERE WAS NO MEDICAL STAFF EXPOSURE AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410052 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER LPZ CHARTER MEDICAL, LTD. CML-75LN 142707

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR