BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANGAROO

    MDR report key: 21401966 · Received February 18, 2025

    Report

    Report Number
    1423537-2025-00084
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    December 13, 2024
    Report Date
    April 30, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LZH
    UDI-DI
    10192253065701
    PMA / PMN Number
    K221603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4 SERIAL NUMBER WAS ADDED

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    A NON-CONFORMANCE OR SERVICE HISTORY REVIEW (SHR) COULD NOT BE CONDUCTED AS NO LOT OR SERIAL NUMBER WAS PROVIDED WITH THE COMPLAINT. THE UNIT WAS NOT RETURNED FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PATIENT HAS A SEVERE FATTY ACID OXIDATION DISORDER REQUIRING A SEVERELY FAT RESTRICTED DIET SUPPLEMENTED WITH MCT BASED FORMULA. FAILURE TO INTAKE ADEQUATE CALORIES CAN RESULT IN SIGNIFICANTLY ELEVATED CREATININE KINASE LEVEL FROM RHABDOMYOLYSIS WHICH CAN CAUSE ORGAN DAMAGE AND COULD POTENTIALLY BE FATAL. THE PATIENT IS ON CONTINUOUS NOCTURNAL G-TUBE FEEDS AND OCCASIONALLY, IN TIMES OF ILLNESS, THROUGHOUT THE DAY AS WELL. THE FEED PUMP WAS SWITCHED (B)(6) 2024, TO THE OMNI M761099. SINCE THEN, THE PUMP HAS BEEN CLOGGING AND BEEPING OFTEN. THIS HAS CAUSED THE PATIENT TO MISS ESSENTIAL CALORIES FROM THE FORMULA FEEDS AT NIGHT, AND SHE HAS BEEN REFUSING TO USE IT DURING THE DAY WHEN SHE REQUIRES IT. ON THE NOTED DATE, SHE WAS SHOWING SYMPTOMS OF RHABDOMYOLYSIS, SO A HIGHER CALORIE FORMULA RECIPE WAS REQUIRED OVERNIGHT. THE PUMP CLOGGED AND MALFUNCTIONED MANY TIMES THROUGHOUT THE NIGHT CAUSING THE PATIENT TO NOT RECEIVE THE REQUIRED CALORIES AND THE PATIENT CONTINUED RHABDOMYOLYSIS SYMPTOMS INTO THE FOLLOWING DAY. THE FORMULA CONCENTRATION IS ~1 KCAL/ML. THE MCT IN THE FORMULA IS LIKELY CAUSING THE PROBLEM WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59866 KANGAROO PUMP, INFUSION, ENTERAL LZH CARDINAL HEALTH 200, LLC 385400 10192253065701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other