BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANGAROO JOEYPUMP W/POLE CLMP

    MDR report key: 12293749 · Received August 9, 2021

    Report

    Report Number
    1282497-2021-10537
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    June 23, 2021
    Report Date
    August 3, 2023
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    UDI-DI
    10884521006645
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 02AUG2023 RESULTING IN THE FOLLOWING SECTIONS BEING UPDATED: A3 ADDED THE PATIENT'S GENDER; B1 SELECTED ADVERSE EVENT; B2 SELECTED DISABILITY OR PERMANENT DAMAGE; B5 ADDED ADDITIONAL VERBIAGE TO THE EVENT DESCRIPTION; D4 ADDED THE DEVICE'S SERIAL NUMBER; H1 UPDATED TO SERIOUS INJURY; H2 SELECTED ADDITIONAL INFORMATION; H6 ADDED CODES TO HEALTH EFFECT ¿ CLINICAL CODE AND HEALTH EFFECT ¿ IMPACT CODE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THAT THERE WAS A HOUSE FIRE WHICH CAUSED SUBSTANTIAL DAMAGES. THERE WERE TWO MEDICAL DEVICES WITHIN THE AREA OF ORIGIN OF THIS FIRE; A KANGAROO JOEY ENTERAL FEED AND FLUSH PUMP, MANUFACTURED BY CARDINAL HEALTH AND SUPPLIED BY OPTION CARE HEALTH, INC.; AND A SU 100 DC PORTABLE SUCTION MACHINE, MANUFACTURED BY SUNSET HEALTHCARE SOLUTIONS, INC AND SUPPLIED BY OTHER COMPANIES. THERE HAS BEEN NO DETERMINATION THAT THE KANGAROO JOEY ENTERAL FEED AND FLUSH PUMP WAS INVOLVED IN THE FIRE. THE INVESTIGATION INTO THE CAUSE OF THE FIRE IS ONGOING. ADDITIONAL INFORMATION RECEIVED 02AUG2023 VIA THE CARDINAL HEALTH LITIGATION TEAM: THE CUSTOMER'S SON WAS LYING ON A BED OF BLANKETS AND PILLOWS WITH THE FEEDING PUMP AND A PORTABLE SUCTION MACHINE NEARBY (SUCTION MACHINE IS A NOT A CARDINAL HEALTH DEVICE). THE CUSTOMER ALLEGES EITHER THE FEEDING PUMP OR THE PORTABLE SUCTION MACHINE MALFUNCTIONED AND STARTED A FIRE. THE CUSTOMER STATED THAT THEIR SON, A QUADRIPLEGIC MINOR, SUFFERED PERMANENT AND SUBSTANTIAL PERSONAL INJURIES INCLUDING THIRD-DEGREE BURNS WHICH REQUIRED EXTENSIVE MEDICAL TREATMENT AND CARE.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE DEVICE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT THERE WAS A HOUSE FIRE WHICH CAUSED SUBSTANTIAL DAMAGES. THERE WERE TWO MEDICAL DEVICES WITHIN THE AREA OF ORIGIN OF THIS FIRE; A KANGAROO JOEY ENTERAL FEED AND FLUSH PUMP, MANUFACTURED BY CARDINAL HEALTH AND SUPPLIED BY (B)(4) AND A SU 100 DC PORTABLE SUCTION MACHINE, MANUFACTURED BY SUNSET HEALTHCARE SOLUTIONS, INC AND SUPPLIED BY OTHER COMPANIES. THERE HAS BEEN NO DETERMINATION THAT THE KANGAROO JOEY ENTERAL FEED AND FLUSH PUMP WAS INVOLVED IN THE FIRE. THE INVESTIGATION INTO THE CAUSE OF THE FIRE IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191023 KANGAROO JOEYPUMP W/POLE CLMP PUMP, INFUSION, ENTERAL LZH COVIDIEN 383400 10884521006645

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Disability