BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10091795 · Received May 27, 2020

    Report

    Report Number
    2016493-2020-01100
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    April 27, 2020
    Report Date
    April 28, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DISREGARD FILE, DEVICE IS NO LONGER A SUSPECT PER FAILURE INVESTIGATION. THE CUSTOMER'S REPORT HAS BEEN CAPTURED UNDER MANUFACTURER REPORT NUMBER 2016493-2020-01096.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WERE DEVICE SYSTEM ERRORS. "PATIENT ID IS INVALID" ERROR MESSAGE OCCURRED ON THE "YELLOW" SCREEN WHEN STAFF WAS ENTERING IN A VALID PATIENT ID. ON THE "GREEN" SCREEN IT IS REPORTED THAT THE ERROR MESSAGE "NETWORK COMM ERROR" ALSO OCCURRED ON THE SAME MODULES AT THE SAME TIME. IT WAS NOTED THAT BOTH ERROR MESSAGES ON ALL INVOLVED MODULES OCCURRED BEFORE PATIENT USE. PER THE REPORTER, THE PUMPS INVOLVED APPEARED TO BE MISSING THE NETWORK CONFIGURATION FILE. AFTER THE NETWORK CONFIGURATION FILE WAS UPLOADED TO THE PUMPS THE "PATIENT ID IS INVALID" NO LONGER OCCURRED ON ALL INVOLVED MODULES.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE DEVICE SYSTEM ERRORS. "PATIENT ID IS INVALID" ERROR MESSAGE OCCURRED ON THE "YELLOW" SCREEN WHEN STAFF WAS ENTERING IN A VALID PATIENT ID. ON THE "GREEN" SCREEN IT IS REPORTED THAT THE ERROR MESSAGE "NETWORK COMM ERROR" ALSO OCCURRED ON THE SAME MODULES AT THE SAME TIME. IT WAS NOTED THAT BOTH ERROR MESSAGES ON ALL INVOLVED MODULES OCCURRED BEFORE PATIENT USE. PER THE REPORTER, THE PUMPS INVOLVED APPEARED TO BE MISSING THE NETWORK CONFIGURATION FILE. AFTER THE NETWORK CONFIGURATION FILE WAS UPLOADED TO THE PUMPS THE "PATIENT ID IS INVALID" NO LONGER OCCURRED ON ALL INVOLVED MODULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555376 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1