BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JYM INFUSION PUMP

    MDR report key: 5719790 · Received June 7, 2016

    Report

    Report Number
    MW5062756
    Event Type
    Injury
    Date Received
    June 7, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 7, 2016
    Manufacturer
    JIAN YUAN MEDICAL TECHNOLOGY CO. LTD
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE WANT TO REPORT PROBLEMS IN MEDICAL INFUSION PUMPS. THE INFUSION PUMP OFTEN USES A DROP SENSOR (DROP COUNTER) TO INCREASE ACCURACY, BUT THIS INFRARED DROP SENSOR CAN BE SPOOFED BY ANOTHER PERSON. THROUGH EXPERIMENTS, WE FOUND OUT THAT THE ATTACKER CAN MANIPULATE THE INFUSED VOLUME OF FLUID WITH HIS OR HER INFRARED SOURCE. THE INFUSED VOLUME CAN BE MANIPULATED FROM 65% TO 330% IN OUR EXPERIMENTS. IT IS BECAUSE THE INFUSION PUMP SENSES DRIPLETS THROUGH THE DROP SENSOR JUST WITH VARIATIONS OF THE OUTPUT OF THE DROP SENSOR. BELOW ARE INFUSION PUMPS THAT WE EXPERIMENTED ON. PRODUCT 1: JSB-1200. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359688 JYM INFUSION PUMP JYM INFUSION PUMP FRN JIAN YUAN MEDICAL TECHNOLOGY CO. LTD JSB-1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other