BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIQ

    MDR report key: 5767911 · Received July 4, 2016

    Report

    Report Number
    2950347-2016-00032
    Event Type
    Death
    Date Received
    July 4, 2016
    Report Date
    January 5, 2017
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS STILL ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. MOSAIQ WORKED AS DESIGNED AND INTENDED. MOSAIQ CALCULATED BSA (BODY SURFACE AREA) USING THE ENTERED HEIGHT AND THEN CAPPED THE BSA AT 3.00. BSA ALERT LIMITS IN OBSERVATION DEFINITIONS WERE SET WITH A WARNING AT 3.00. THE SYSTEM DID INDICATE A WARNING BY HIGHLIGHTING THE BSA IN YELLOW ON THE CLINICIAN WORKSHEET. THE CALCULATED BSA USING THE HEIGHT AND WEIGHT ENTERED WOULD BE 73.40 (DUBOIS DUBOIS). MOSAIQ SHOULD BE CONFIGURED BY THE USER TO SHOW WARNING LEVELS ON HEIGHT AND WEIGHT. AS THE HEIGHT AND WEIGHT LEVELS WERE NOT CONFIGURED BY THE USER WITH ADDITIONAL WARNING CRITERIA THERE WERE NO ADDITIONAL WARNINGS PRESENTED TO THE USER. THE HEIGHT, WEIGHT AND BSA ARE PRESENTED TO THE PHYSICIAN TO CONFIRM WHAT INFORMATION WAS USED IN THE CALCULATIONS DURING THE DRUG APPROVAL PROCESS. MOSAIQ DOES NOT PREVENT AN ORDER FROM BEING APPROVED BASED ON THESE WARNINGS. THIS WAS A CASE OF ABNORMAL USE AND THE WARNINGS WERE NOT OBSERVED BY THE USERS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A MEDICAL ASSISTANT ENTERED THE PATIENTS WEIGHT AS (B)(6) LBS AND HEIGHT AS 12050 INCHES IN MOSAIQ. THE BSA AND BMI WERE BOTH FLAGGED YELLOW BY THE SYSTEM. THE PATIENT RECEIVED INFUSION CALCULATED WITH THIS HEIGHT, WHICH WAS CHECKED BY THE PHARMACIST, PHYSICIANS AND TWO INFUSION NURSES. THE PATIENT WENT INTO CARDIAC ARREST AND HAS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421961 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE IMPAC MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death