BEUDAMED
    FDA Adverse Event Other Summary report: N

    KANGAROO EPUMP-NEW

    MDR report key: 3671916 · Received February 20, 2014

    Report

    Report Number
    3006451981-2014-00533
    Event Type
    Other
    Date Received
    February 20, 2014
    Report Date
    February 11, 2014
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    LZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING PUMP. THE CUSTOMER STATES THAT THE NURSES WERE USING THE PUMP, THE PT WAS NOT FED THE PROPER AMOUNT. THE CUSTOMER STATES THAT THE RN THOUGHT THE PUMP WAS PUMPING BUT IT WAS NOT. THE CUSTOMER CHECKED THE PUMP AND IT SEEMS TO BE FUNCTIONING NOW. THE CUSTOMER STATES THAT WHEN THEY PULL THE CORD LIGHTLY, THE DISPLAY GOES OUT BUT THE LIGHTS ARE ON. THE CUSTOMER STATED THAT THE NURSES ADVISED THE ROTOR WAS NOT TURNING. THE CUSTOMER FURTHER STATED THAT THE PATIENT RECEIVED TREATMENT FOR AN HYPOGLYCEMIC EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106505 KANGAROO EPUMP-NEW FEEDING PUMP LZH COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC 382400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other