BEUDAMED
    FDA Adverse Event Other Summary report: N

    KANGAROO EPUMP - NEW

    MDR report key: 3844691 · Received May 15, 2014

    Report

    Report Number
    3009247326-2014-00007
    Event Type
    Other
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 28, 2014
    Manufacturer
    JABIL SINGAPORE
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING PUMP. THE CUSTOMER REPORTS THAT THE PUMP HAS A BAD VALVE SELECTOR THAT JUST SPINS IN CIRCLES RATHER THAN SELECTING THE FLUSH OR FEED LINE AND THERE IS NO ALARM WHEN THIS OCCURS, THE PUMP CONTINUES TO OPERATE. THE CUSTOMER STATES THAT AFTER THE SET AMOUNT OF FLUID IS DELIVERED ON A FEED ONLY SETTING, THE PUMP TELLS THE USER THAT IT DELIVERED THE CORRECT AMOUNT. THE CUSTOMER ALSO STATES THAT THE VOLUME THE PUMP DELIVERS IS CORRECT BUT WHEN THEY MEASURE THE OUTPUT FROM THE FEED AND FLUSH SEPARATELY, THEY FIND THAT EVEN THOUGH THE PUMP WAS SET TO FEED, IF THE VALVE IS BAD, IT DELIVERS ALMOST EXACTLY HALF THE VOLUME FROM THE FEED AND THE FLUSH WITHOUT EVER ALERTING THE USER THAT THERE IS AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291497 KANGAROO EPUMP - NEW FEEDING PUMP LZH JABIL SINGAPORE 382400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN