BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 20178472 · Received September 10, 2024

    Report

    Report Number
    3015232217-2024-00028
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K203172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE INVESTIGATION FOUND THAT BLEOMYCIN DRUG ORDER WAS CREATED INCORRECTLY BY THE USER FOR A FEW PATIENTS. THE DOSE WAS SET TO 30 UNITS/M2 INSTEAD OF 30 UNITS. THE INCORRECT CARE PLAN WAS APPROVED BY THE PHYSICIAN WHICH WAS THEN ADMINISTERED TO PATIENTS. FOR ONE OF THE PATIENTS, THE DOSE WAS CORRECTED PRIOR TO APPROVAL AND THERE WAS NO MISTREATMENT. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED. THE ROOT CAUSE OF THE DOSE ERROR WAS DUE TO USE ERROR. ELEKTA PHYSICISTS HAVE ASSESSED THIS ISSUE TO BE SERIOUS MISTREATMENT, HOWEVER ALL THE PATIENTS THAT WERE TREATED WITH THE INCORRECT DOSE HAVE FULLY RECOVERED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BLEOMYCIN DOSE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331086 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other