BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MVE CRYO SHIPPER

    MDR report key: 501902 · Received December 5, 2003

    Report

    Report Number
    MW1030483
    Event Type
    Malfunction
    Date Received
    December 5, 2003
    Date of Event
    October 30, 2003
    Report Date
    November 25, 2003
    Manufacturer
    CHART INDUSTRIES, APPLIED TECHNOLOGIES DIVISION
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MVE CRYO SHIPPER, ENCLOSED IN A PROTECTIVE OUTER SHIPPING CONTAINER PURCHASED FROM THE MANUFACTURER, WAS UTILIZED TO SHIP A PERIPHERAL BLOOD STEM CELL ("PBSC") TO HOSP, THE SHIPMENT WAS PREPARED IN ACCORDANCE WITH STANDARD PROCEDURES, SHIPPED AND ARRIVED AT THE CONSIGNEE WITHIN 15 HRS. UPON RECEIPT, THE CONSIGNEE OBSERVED THAT THE PBSC WAS PARTIALLY THAWED AND THEREFORE NON-VIABLE FOR ITS INTENDED USE. THE CONTAINER WAS RETURNED, SUBJECTED TO A PREPARATION CYCLE IN ACCORDANCE WITH STANDARD PROCEDURES, AND ALLOWED TO STAND OVERNIGHT. UPON OPENING, THE INTERIOR WAS FOUND TO BE WARM, THUS CONFIRMING THAT THE DEVICE HAD FAILED. THE MANUACTURER WAS INFORMED OF THE INCIDENT AND INDICATED THAT THE INTEGRITY OF THE DEVICE COULD FAIL IF IT WAS DROPPED OR PLACED ON ITS SIDE OR UPSIDE-DOWN. THESE CRITICAL LIMITATIONS ARE UNCLEAR IN THE MANUFACTURER'S INSTRUCTIONS. IN ADDITION, THE MANUFACTURER INDICATED THAT UNITS OVER 10 YEARS OLD "FAIL OFTEN". THE DEVICE IN QUESTION WAS MANUFACTURED IN 1991 AND PURCHASED AND VALIDATED BY FACILITY IN 1999. THE MANUFACTURER'S INSTRUCTIONS/PACKAGE INSERT DOES NOT CONTAIN ANY STATEMENT CONCERNING THE DEVICE LIFESPAN. IN ADDITION, THE MANUFACTURER'S PROTECTIVE OUTER PACKAGING DOES NOT CONTAIN PROMINENT WARNINGS THAT THE DEVICE IS FRAGILE OR MUST BE SHIPPED IN AN UPRIGHT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MVE CRYO SHIPPER CRYOGENIC SHIPPING CONTAINER KSR CHART INDUSTRIES, APPLIED TECHNOLOGIES DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *