BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11044745 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-73884
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    October 21, 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

    INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. 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 TRACK WISE CANNOT BE CONDUCTED. THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE DESCRIPTION: TECH, CALLED IN FOR HELP ON 8100 UNIT SERIAL # (B)(4). FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT. FAILURE PROBLEM TYPE: 8100. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: TECH, HAS A VERY OLD 8100 UNIT GIVEN HIM A FLOW STOP ERROR, BEFORE CALL IN HE HAD REPLACE THE PRESSURE SENSOR & THE AIL SENSOR AND STILL GET SAME ERROR NEXT IS THE MAIN BOARD ON UNIT HAS TO BE REPLACE, IF THAT DOES NOT RESOLVE THE ISSUE UNIT HAVE TO BE SERVICES TECH THANK ME FOR MY ASSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515890 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1