BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 13838874 · Received March 21, 2022

    Report

    Report Number
    2016493-2022-745139
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    November 15, 2019
    Report Date
    November 15, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2822-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THE FAILURE MODE: DISPLAY BOARD - SEGMENT DIM, IMDRF CODE A090202, NO FURTHER COMPLAINT INVESTIGATION IS NECESSARY AS CAPA 1143616 WAS OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    THE INFORMATION PROVIDED WAS OBTAINED FROM A RETROSPECTIVE REVIEW OF SERVICING DATA; THEREFORE, NO OTHER INFORMATION IS OBTAINABLE AT THIS TIME. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550820 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 ALARIS LVP MODULE 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown