BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLINICIAN PROGRAMMER

    MDR report key: 15502250 · Received September 29, 2022

    Report

    Report Number
    3010079947-2022-00176
    Event Type
    Death
    Date Received
    September 29, 2022
    Date of Event
    August 22, 2022
    Report Date
    August 29, 2022
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INFORMATION WAS NOT PROVIDED, AND THEREFORE, IT HAS NOT BEEN DEFINITIVELY CONFIRMED THAT THE INCIDENT INVOLVES A FLOWONIX DEVICE. AS SPECIFIC DEVICE INFORMATION IS UNAVAILABLE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. SEVERAL ATTEMPTS WERE MADE TO FOLLOW UP WITH THE OFFICE TO OBTAIN MORE INFORMATION, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE CAUSE OF THE PATIENT'S DEATH WAS NOT ABLE TO BE CONFIRMED AND OR INVESTIGATED ANY FURTHER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SENT. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    PHYSICIAN CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT DEATH. THE PHYSICIAN STATED THAT THE PATIENT FELT FINE AFTER A REFILL APPOINTMENT, BUT THEN WENT HOME AND EXPIRED DUE TO RESPIRATORY DISTRESS AND POTENTIAL OVERDOSE. PHYSICIAN STATED THAT THEY PROGRAMMED A .221 (UNKNOWN UNIT) DOSE ON THEIR PROGRAMMER BUT LATER LEARNED THAT A .65 (UNKNOWN UNIT) DOSE WAS PROGRAMMED. THE PHYSICIAN ALLEGED THAT THE PROGRAMMER WAS RESPONSIBLE FOR CHANGING THE PROGRAMMED VALUES FOR THE DAILY DOSE, LEADING TO THE INCIDENT. TECHNICAL SOLUTIONS REQUESTED PATIENT INFORMATION, DEVICE INFORMATION, AND TELEMETRY REPORTS FROM THE PROGRAMMER, BUT THIS INFORMATION WAS NOT PROVIDED BY THE PHYSICIAN. FOLLOWING THE INITIAL CALL, ANY ADDITIONAL FOLLOW-UP ATTEMPTS WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2927942 CLINICIAN PROGRAMMER CLINICIAN PROGRAMMER LKK FLOWONIX MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death