BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10948249 · Received December 4, 2020

    Report

    Report Number
    2016493-2020-56684
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Report Date
    February 1, 2019
    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 RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). RESOLVE CUSTOMER ISSUE EXPLAIN TO HER REGARDING ERROR COD E100-1250. HAS TO DO WITH THE LOGIC BOARD ON UNIT IT IS A UNKNOWN BOARD TYPE DETECTED ON THE OPTION BOARD SLOT. CUSTOMER PREFER TO SEND UNIT IN FOR REPAIR SERVICES UNIT IS UNDER WARRANTY REPAIR. (B)(4). CUSTOMER CALLED IN FOR HELP ON 8015 UNIT HAS CA ERROR CODE 100-1250 WHICH THE ERROR CODE HAS TO DO WITH THE LOGIC BOARD ON UNIT WILL HAVE TO BE REPLACE. THE ERROR IS CAUSE AN UNKNOWN BOARD TYPE IS DETECTED IN THE OPTION BOARD SLOT. SHE CAN REMOVE & REPLACE THE OPTION BOARD, CUSTOMER PREFER TO SEND UNIT IN UNDER WARRANTY REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413463 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1