BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 3987504 · Received June 11, 2014

    Report

    Report Number
    3006803715-2014-00011
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    FLOWONIX MEDICAL INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DID NOT IMPACT THE PATIENT SINCE THE FAILURE TO COMMUNICATE WITH THE PUMP WAS RECOGNIZED BEFORE THE IMPLANT PROCEDURE. THE PUMP HAS BEEN RETURNED TO OUR MANUFACTURING FACILITY FOR INVESTIGATION. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE PUMP WOULD NOT COMMUNICATE WITH THE PROGRAMMER DURING PRIMING FOR IMPLANT. A SECOND PUMP WAS USED TO COMPLETE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346150 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1