BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPUMP 1000ML PUMP SET

    MDR report key: 3766775 · Received April 9, 2014

    Report

    Report Number
    1282497-2014-00022
    Event Type
    Other
    Date Received
    April 9, 2014
    Report Date
    March 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 SET. THE CUSTOMER STATES THAT THEY NOTICED THAT THEIR DAUGHTER'S FEEDING PUMP WAS WAY OVER HER FEEDING AMOUNT WHICH THEY ASSUMED WAS A FEEDING PUMP ISSUE. THE CUSTOMER USES THE MEASUREMENTS ON THE FEEDING BAG WHICH THEY WERE ASSUMING WERE CORRECT. HOWEVER THE CUSTOMER MEASURED OUT BY ML AND FILLED THE BAG TO 400 ML, THIS SHOWED THAT THE ML MEASUREMENTS WERE WAY OFF. THE CUSTOMER FURTHER STATED THAT THEY NOTICED THEIR DAUGHTER WAS BLOATED AND DURING CAUTERIZATION THEY WERE GETTING EXCESSIVE AMOUNT OF URINE WHICH THEY BELIEVE THIS MAY HAVE CAUSED HER STRESS. THE CUSTOMER USES PROMOTE WITH FIBER FORMULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214873 EPUMP 1000ML PUMP SET FEEDING SET FPD COVIDIEN 773656 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other