BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 5088825 · Received September 18, 2015

    Report

    Report Number
    3006803715-2015-00063
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 23, 2015
    Report Date
    August 23, 2015
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM FOR COMPLICATIONS RELATED TO HIGH DOSE OF OPIOIDS. AFTER BEING TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), NARCAN WAS ADMINISTERED AND THE PATIENT WAS ABLE TO STABILIZE. THE DAILY DOSE WAS DECREASED. REVIEW OF THE PATIENT HISTORY SHOWED THAT THE DAILY DOSE HAD NOT BEEN CHANGED SINCE (B)(6) 2015. THERE WERE NO PRODUCT ISSUES OBSERVED. IT WAS REPORTED THAT THE PATIENT HAD ACCESS TO UN-PRESCRIBED SLEEPING PILLS. ON (B)(6) 2015, THE PATIENT UNDERWENT AN MRI PROCEDURE WITHOUT PROPERLY FOLLOWING THE PRE-MRI PROCEDURE FROM THE INSTRUCTIONS FOR USE (IFU) AND BECAME UNCONSCIOUS. THE PATIENT STABILIZED SHORTLY AFTER AND THE PUMP WAS SHUT OFF ON (B)(6) 2015.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PUMP RESERVOIR WAS CHECKED ON (B)(6) 2015 AND FOUND TO BE EMPTY. THE PUMP THERAPY WAS CONTINUED AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618538 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O