BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 14392842 · Received May 13, 2022

    Report

    Report Number
    2016493-2022-144272
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    January 14, 2021
    Report Date
    September 6, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. HOWEVER, IT CONTAINS THE FOLLOWING IMDRF CODES: (B)(4). THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. HOWEVER, IT CONTAINS THE FOLLOWING IMDRF CODES: E2403 - NO CLINICAL SIGNS SYMPTOMS OR CONDITIONS A110701 - LOSS OF DATA A0719 - UNEXPECTED SHUTDOWN F26 - NO HEALTH CONSEQUENCES OR IMPACT THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM HEALTH CANADA REGARDING AN EVENT THAT WAS SUBMITTED BY THE USER FACILITY TO THE CANADA VIGILANCE PROGRAM. THE REPORT DID NOT HAVE THE DETAILS OF THE EVENT. HOWEVER, IT CONTAINS THE FOLLOWING IMDRF CODES: E2403 - NO CLINICAL SIGNS SYMPTOMS OR CONDITIONS A110701 - LOSS OF DATA A0719 - UNEXPECTED SHUTDOWN F26 - NO HEALTH CONSEQUENCES OR IMPACT THERE WAS PATIENT INVOLVEMENT. A REPORT WAS RECEIVED FROM HEALTH CANADA'S CANADA VIGILANCE PROGRAM WHICH STATES, "INFUSION PUMP WAS PLUGGED IN AND POWERED DOWN UNEXPECTEDLY. WHEN RESTARTED DATA FROM PT WAS NOT SAVED HAD TO REPROGRAM PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667958 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015| 8015