BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12511860 · Received September 22, 2021

    Report

    Report Number
    2016493-2021-61699
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    September 2, 2021
    Report Date
    February 23, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION: IMDRF ANNEX A,B,C,D AND G CODES AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT HAD OOB-POWER FAILURE WITH ERROR CODE 120-4540. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    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 THE UNIT HAD OOB-POWER FAILURE WITH ERROR CODE 120-4540. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410696 ALARIS SYSTEM INFUSION PUMP FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1