BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP CKV 3SS DEHP FREE

    MDR report key: 12014118 · Received June 16, 2021

    Report

    Report Number
    9616066-2021-51327
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 28, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403227996
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.INVESTIGATION SUMMARY:ONE SAMPLE AND ONE PHOTO WAS PROVIDED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF COSMETIC ISSUES - DISCOLORED WAS VERIFIED BY VISUAL INSPECTION. THE DRIP CHAMBER SUBMITTED APPEARS TO HAVE A DARKER TINT IN COLORING. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0007 LOT NUMBER 19016697 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 17,283 UNITS IN 1 LOT NUMBER WAS BUILT ON 25JAN2019. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE FOR THE DISCOLORATION OF THE DRIP CHAMBER IS A RESULT OF THE RADIATION STERILIZATION PROCESS. THE LIGHT AMBER HUE OF THE RETURNED SAMPLE IS CONSIDERED TO BE A TYPICAL OCCURRENCE AND IS PURELY COSMETIC; STERILITY AND FUNCTIONALITY ARE NOT AFFECTED. THE STERILIZATION CERTIFICATE WAS PROVIDED TO SHOW THE METHOD OF STERILIZATION (GAMMA) AND TO CONFIRM THAT THE AFFECTED LOT WAS PROCESSED WITHIN SPECIFICATION. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2426-0007. BATCH/ LOT #: 19016697. ONE OF THE HFHS CLINICS IS QUESTIONING IF THEY ARE ABLE TO USE TUBING THAT IS SLIGHTLY DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906480 GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2426-0007 19016697 50885403227996

    Patients

    Seq Age Sex Outcome Treatment
    1