BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7-IN PRESSURE RATED SET W/ MAXPLUS

    MDR report key: 11520808 · Received March 18, 2021

    Report

    Report Number
    9616066-2021-50498
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 19, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403236653
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE AND ONE PHOTO WERE RECEIVED FOR INVESTIGATION. THE CUSTOMER'S PHOTO CLEARLY SHOWS THE VALVE STUCK IN AN OPEN POSITION WHICH VERIFIED THE LEAKAGE. THE SAMPLE WAS REPEATEDLY TESTED TO TRY TO FORCE THIS FAILURE BUT THE FAILURE WAS NOT REPLICATED. VISUAL ANALYSES UNDER MICROSCOPE WAS EMPLOYED TO FURTHER INVESTIGATE POSSIBLE REASONS FOR FAILURE. THE MAXPLUS CONNECTOR SHOWED POSSIBLE DISCOLORATION BUT IT CANNOT BE CONFIRMED WHETHER THIS HAPPENED DURING PRODUCTION OR AFTER USE BY CUSTOMER. THE ROOT CAUSE OF THIS FAILURE IS UNKNOWN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW FOR MODEL MP5303-C LOT NUMBER 20125868 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. CAPA#844986 WAS INITIATED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE WITH LOT #20125868 REGARDING ITEM # MP5303-C. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 7-IN PRESSURE RATED SET W/ MAXPLUS LEAKED DUE TO COMPRESSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLUE PLASTIC INSIDE STAY COMPRESS ALL THE TIME, THEREFORE THE FLUID LEAKED".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 7-IN PRESSURE RATED SET W/ MAXPLUS LEAKED DUE TO COMPRESSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLUE PLASTIC INSIDE STAY COMPRESS ALL THE TIME, THEREFORE THE FLUID LEAKED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417171 7-IN PRESSURE RATED SET W/ MAXPLUS INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MP5303-C 20125868 50885403236653

    Patients

    Seq Age Sex Outcome Treatment
    1