BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 4308430 · Received November 20, 2014

    Report

    Report Number
    3006803715-2014-00042
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    FLOWONIX MEDICAL INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE DEVICE IS EXPLANTED AND RETURNED FOR INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WOULD NOT INQUIRE DURING A REFILL VISIT. THE PUMP WAS STOPPED AND THE DRUG RESERVOIR WAS EMPTIED OUT. A 15 ML WAS REMOVED FROM THE RESERVOIR. A BACKUP PROGRAMMER WAS USED BUT RESULTED IN THE SAME ISSUES. THE PT WAS SCHEDULED FOR EXPLANT AND THE DEVICE WILL BE RETURNED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755216 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1