BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 6967003 · Received October 20, 2017

    Report

    Report Number
    3010079947-2017-00150
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    July 7, 2017
    Report Date
    September 22, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020082
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO AN OVERDOSE THAT RESULTED IN ADDITIONAL HOME THERAPY TREATMENTS. IT WAS NOTED THAT THE NURSE, AT THE TIME, CHANGED THE CONCENTRATION OF THE DRUG BUT DID NOT UPDATE THE CONCENTRATION IN THE PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744989 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827 00810335020082

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O