BEUDAMED
    FDA Adverse Event Other Summary report: N

    KANGAROO EPUMP- NEW

    MDR report key: 3058140 · Received April 3, 2013

    Report

    Report Number
    3006451981-2013-00089
    Event Type
    Other
    Date Received
    April 3, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    LZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A KANGAROO E-PUMP. THE CUSTOMER REPORTS, FEED STARTED AT 9:50 AM ON (B)(6) 2013. FEED RATE SET AT 75ML PER HOUR. VOLUME TO BE DELIVERED SET AT 75ML PER HOUR. VOLUME TO BE DELIVERED SET AT 825ML. FLUSH SET AT 275ML EVERY 4 HOURS. NURSE DELIVERED MEDICATIONS AT 1:30PM, THEN CLEARED THE VOLUME POST-DELIVERY OF MEDICATIONS AROUND 2:00, PER FACILITY PROTOCOL. PUMP AND VOLUME APPEARED NORMAL AT THIS TIME. AT APPROX. 3:45 PM ON (B)(6) 2013, THE CHARGE NURSE NOTICED THE READY TO HANG NUTRITION BOTTLE WAS EMPTY. HE CHECKED THE PUMP AND FEED RATE READ 275ML PER HOUR. THE VOLUME DELIVERED READ 1089ML. PATIENT WAS DISCONNECTED AND HE POWERED THE PUMP DOWN. HE THEN RETRIEVED THE NURSE IN CHARGE OF THE PATIENT. WHEN HE POWERED THE PUMP BACK ON THE PUMP READ 75ML PER HOUR, AND THE VOLUME DELIVERED READ 529ML. THE VOLUME TO BE DELIVERED READ 825 ML STILL. THE DIRECTOR OF NURSING, ADMINISTRATOR, AND CHARGE NURSE THEN LOOKED IN THE HISTORY SETTINGS AND WERE UNABLE TO RETRIEVE ANY HISTORY SETTINGS UNTIL THEY WENT BACK 14 HOURS IN TIME. THE PUMP WAS READING 0ML FED AND 0ML FLUSHED UNTIL 14 HOURS PRIOR TO INCIDENT. NURSE OBTAINED RESIDUAL VOLUME OF 549ML FROM PATIENT¿S STOMACH. MEDICAL DIRECTOR NOTIFIED, PATIENT SENT TO (B)(6) TO BE EVALUATED. PATIENT WAS ADMITTED ON (B)(6) 2013 AT APPROXIMATELY 1:00AM WITH PRIMARY DIAGNOSIS OF PNEUMONIA. ON (B)(6) 2013, PATIENT IS STATED AS HAVING RETURNED HOME AND IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137556 KANGAROO EPUMP- NEW E-PUMP LZH COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC 382400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization