BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV MC 4SS 20DP 10PK DEHP FREE

    MDR report key: 10304770 · Received July 21, 2020

    Report

    Report Number
    9616066-2020-02269
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 22, 2020
    Report Date
    June 29, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    37613203019195
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO AND ONE SAMPLE OF MODEL 10821753 BURETTE SET WAS RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE RECEIVED SAMPLES, AND IN COMPARISON TO THE CURRENT ASSEMBLY DRAWING, IT WAS VERIFIED THAT THE WHITE TUBE CLAMP ON THE BOTTOM OF THE PUMPING SEGMENT TUBING (P/N TC10006064) IS MISSING FROM THE CONSTRUCTION. THE ROOT CAUSE WAS IDENTIFIED AS A MISASSEMBLY OF THE SET DURING THE MANUFACTURING PROCESS. NO TESTING WAS PERFORMED AS THE MISASSEMBLY WAS OBVIOUS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 10821753 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: B.3. DATE OF EVENT: (B)(6) 2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF GEM V/NV MC 4SS 20DP 10PK DEHP FREE EXPERIENCED A MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR SURGICAL SERVICES DEPT ENCOUNTERED AN ISSUE WITH THE BURRETTE SET WHERE THE WHITE CLAMP WAS MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF GEM V/NV MC 4SS 20DP 10PK DEHP FREE EXPERIENCED A MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR SURGICAL SERVICES DEPT ENCOUNTERED AN ISSUE WITH THE BURRETTE SET WHERE THE WHITE CLAMP WAS MISSING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF GEM V/NV MC 4SS 20DP 10PK DEHP FREE EXPERIENCED A MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR SURGICAL SERVICES DEPT ENCOUNTERED AN ISSUE WITH THE BURRETTE SET WHERE THE WHITE CLAMP WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764829 GEM V/NV MC 4SS 20DP 10PK DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 10821753 UNKNOWN 37613203019195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other