BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 12192966 · Received July 19, 2021

    Report

    Report Number
    3010079947-2021-00208
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    June 22, 2021
    Report Date
    June 22, 2021
    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

    A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE PUMP, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE PUMP, VERIFICATION OF STERILIZATION, AND PACKAGING FOR SUBJECT PUMP WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, ISSUES OR CAPAS ASSOCIATED WITH PUMP FUNCTION. DEVICE WAS NOT RETURNED FOR ADDITIONAL EVALUATION AND INVESTIGATION. AS THE DEVICE WAS NOT RETURNED FOR ADDITIONAL INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE ALLEGED ISSUE. (B)(4).

    Description of Event or Problem · 1

    CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP EXPLANT. ADDITIONAL COMMUNICATION WITH A REPRESENTATIVE FROM THE PHYSICIAN'S OFFICE CONFIRMED THAT THE PHYSICIAN MENTIONED THAT THE PATIENT " WAS NOT GETTING THE MEDICATION" AND THAT THE PATIENT WANTED TO KEEP THE PUMP. THERE WAS NO INFORMATION PROVIDED OR AVAILABLE REGARDING VOLUME DISCREPANCIES, OTHER DIAGNOSTIC STUDIES, OR ANY OTHER SPECIFIC DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083963 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 11827 19847 00810335020082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention