BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11154500 · Received January 12, 2021

    Report

    Report Number
    2016493-2021-06237
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Report Date
    March 4, 2020
    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

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. 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

    (B)(4). CASE DESCRIPTION: CALLER HAS AN 8015 UNIT GIVING A 133.6080 ERROR. FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: ERROR NOT DUE TO LOW BATTERY. USED KA 11952 ALARIS INFUSION ERROR 133.6080. RECOMMENDED TO SEND UNIT IN FOR WARRANTY REPAIR. BIOMED WILL GET RMA FROM REPAIR PORTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53727 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1