BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 5001802 · Received August 13, 2015

    Report

    Report Number
    3006803715-2015-00052
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020082
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING A REFILL APPOINTMENT, IT WAS REPORTED THAT THE LOW RESERVOIR VOLUME WAS NOT HEARD AND A MINIMAL VOLUME HIGHER THAN EXPECTED WAS OBSERVED IN THE PUMP. THE LOW RESERVOIR ALARM WAS VERIFIED TO BE ON. THERE WERE NO PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    THERE HAVE BEEN NO ADDITIONAL ISSUES REPORTED AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533533 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827 00810335020082

    Patients

    Seq Age Sex Outcome Treatment
    1