BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM

    MDR report key: 12075070 · Received June 28, 2021

    Report

    Report Number
    2016493-2021-54870
    Event Type
    Death
    Date Received
    June 28, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 6, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT, WHICH CAPTURED THE SUSPECT DEVICE S/N (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SUSPICIOUS DEATH AT THE MEDICAL CENTER INVOLVING INFUSION PUMPS THAT WERE ALLEGEDLY BEING PAUSED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). THE ACTUAL DATE OF EVENT IS UNKNOWN. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUSPICIOUS DEATH AT THE MEDICAL CENTER INVOLVING INFUSION PUMPS THAT WERE ALLEGEDLY BEING PAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970917 ALARIS SYSTEM INFUSION PUMP FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 8015| 8015