BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10894792 · Received November 24, 2020

    Report

    Report Number
    2016493-2020-45710
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Report Date
    October 17, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). (B)(6) HAD AN ERROR CODE 600.6835 ON PCU8015. SHE GOT AN ERROR MESSAGE: "SELECTED PCU UNIT RF CARD NOT DETECTED" WHEN SHE TRANSFER NETWORK CONFIGURATION. I HAD HER RUN THE TASK "DISABLE WIRELESS NETWORK CONFIGURATION" TO SEE IF IT WILL CLEAR THE ERROR 600.6835. AFTER SHE RAN THE TASK "DISABLE WIRELESS NETWORK CONFIGURATION", THE ERROR CODE STILL EXISTS. I ADVISED (B)(6) TO RE-FLASH POC SOFTWARE (B)(4) ON HER PCU. GAVE HER INSTRUCTION. GAVE HER PART NUMBER FOR CF CARDS AND TRANSFERRED HER TO COM FOR PRICING. SENT A REQUEST TO HAVE POC SOFTWARE (B)(4) CD SHIPPED TO HER. SHE WILL CALL TECH SUPPORT TO HELP HER SET UP SOFTWARE ON THE CF CARDS AND FLASH THE SOFTWARE, WHEN SHE GOT EVERYTHING READY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357503 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1