BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11266330 · Received February 2, 2021

    Report

    Report Number
    2016493-2021-22052
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Report Date
    July 29, 2020
    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

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. 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 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

    CASE #: (B)(4). CASE SUBJECT: NPI 8015 ALARIS PC FLASHING TO OLDER VERSION. ACCOUNT NAME: (B)(6) MEDICAL CENTER [(B)(6) MEDICAL CENTER]. ACCOUNT #: (B)(6). ASSET NAME: 8015LS PCU DOM V9.19.1.2 A/B/G/N. CONTACT:(B)(6). PATIENT OR USER INVOLVEMENT: NO. PATIENT OR USER HARM: NO. CASE DESCRIPTION: CUSTOMER IS ATTEMPTING TO FLASH ALARIS PC TO OLDER VERSION AND RECEIVES AN ERROR MESSAGE "PC IS FIPS ENABLED, PLEASE REFER TO CF CARD FLASHING PROCEDURE" . SN: (B)(4). CASE RESOLUTION: FLASHING LOGIC BOARD; GAVE PART NUMBER TO EXTENDER BOARD WITH COMPACT FLASH CARDS. LET HIM KNOW TO CONTACT US ONCE HE GETS THESE PARTS. TRANSFER TO COM FOR OFFICIAL PRICE QUOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164803 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1