BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11008202 · Received December 15, 2020

    Report

    Report Number
    2016493-2020-68371
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Report Date
    May 1, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    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 NOT PERFORMED BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FOR THE SUSPECT DEVICE. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. (B)(4). BILL HAD A NEW PCU8015 DID NOT UPDATE DATA SET BECAUSE IT WAS NOT CONNECTED TO SERVER. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT. FAILURE PROBLEM TYPE: 8015. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: I REMOTE IN TO BILLS' COMPUTER TO ASSIST HIM SET UP NETWORK CONFIGURATION PACKAGE AND TRANSFER NETWORK CONFIGURATION TO THE PCU. WE COULD NOT EXPORT NETWORK PROFILE FROM A WORKING PCU BECAUSE IT WAS FIP ENABLE. I ADVISED BILL TO CONTACT HIS IT TO OBTAIN HIS HOSPITAL NETWORK CONFIGURATION PACKAGE. I SHOW HIM HOW TO IMPORT NETWORK PROFILE TO ALARIS SYSTEM MAINTENANCE SOFTWARE CONFI REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475455 8015 ALARIS SYSTEM PC UNIT PUMP,INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1