BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ENTERAL FEEDING

    MDR report key: 16437209 · Received February 24, 2023

    Report

    Report Number
    1282497-2023-10739
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 24, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. SINCE THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THE FAILURE COULD NOT BE CONFIRMED THEREFORE THE ROOT CAUSE AND CORRECTIVE ACTIONS COULD NOT BE IDENTIFIED. THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION. IF SAMPLE IS RECEIVED LATER, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION SUMMARY WAS SENT TO THE QRA INBOX FOR TRANSLATION AND ONCE TRANSLATED, THE REGION WILL ATTACH THE CLOSURE LETTER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING HANDOFF THE RN WAS NOTIFIED THAT THE PATIENT HAD DEVELOPED NAUSEA AND VOMITING OVERNIGHT WHICH REQUIRED A PRN ORDER FOR ZOFRAN. ON ASSESSMENT EARLY IN THE AM, THE RN NOTICED FEEDS LEAKING FROM THE KANGAROO PUMP. IT WAS NOTED THAT THE PLASTIC TUBING EXITING THE PURPLE CARTRIDGE THAT PLUGS INTO THE KANGAROO PUMP HAD BECOME PARTIALLY DISLODGED. THIS AREA OF DISCONNECTION WAS ALLOWING THE ENTERAL FEEDS TO EXIT THE PATIENT'S TUBING AS WELL AS INTAKING AIR WHICH WAS THEN BEING PUMPED THROUGH THE TUBING INTO THE PATIENT'S STOMACH. THIS COULD HAVE BEEN A CONTRIBUTION TO THE PATIENT¿S NAUSEA AND SUBSEQUENT VOMITING THAT LED TO TWO DOSES OF ZOFRAN BEING GIVEN AND A DELAY IN HER MORNING MEDICATIONS. PER THE CUSTOMER, ALL KNOWN INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858591 UNKNOWN ENTERAL FEEDING PUMP, INFUSION, ENTERAL LZH CARDINAL HEALTH UNKNOWN ENTERAL FEEDING

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown