BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP CKV 3SS DEHP FREE

    MDR report key: 11773977 · Received May 4, 2021

    Report

    Report Number
    9616066-2021-50887
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 20, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF FOREIGN MATTER WAS VERIFIED BY VISUAL INSPECTION. EVALUATION OF THE UNUSED SAMPLE SHOWS EVIDENCE OF FOREIGN MATTER ON THE SPIKE OF THE DRIP CHAMBER AND ON THE INSIDE OF THE SPIKE COVER. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0007 LOT NUMBER 20129017 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 34,563 UNITS IN 1 LOT NUMBER WAS BUILT ON 12DEC2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE OF THE FOREIGN MATTER IS GREASE FROM THE MANUFACTURING PROCESS OF THE DRIP CHAMBER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: ONE SAMPLE WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF FOREIGN MATTER WAS VERIFIED BY VISUAL INSPECTION. EVALUATION OF THE UNUSED SAMPLE SHOWS EVIDENCE OF FOREIGN MATTER ON THE SPIKE OF THE DRIP CHAMBER AND ON THE INSIDE OF THE SPIKE COVER. THE ROOT CAUSE OF THE FOREIGN MATTER IS GREASE FROM THE MANUFACTURING PROCESS OF THE DRIP CHAMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2426-0007. BATCH/ LOT #: 20129017. IT WAS REPORTED THAT A FOREIGN MATTER WAS IDENTIFIED ON THE TUBING SET. OUR RN OPENED A NEW PACKAGE OF THIS TUBING 2426-0007 AND FOUND THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669002 GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20129017

    Patients

    Seq Age Sex Outcome Treatment
    1