BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 11197178 · Received January 19, 2021

    Report

    Report Number
    3010079947-2021-00026
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    December 24, 2020
    Report Date
    December 24, 2020
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR ADDITIONAL EVALUATION AND INVESTIGATION. 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. ADDITIONAL PHYSICAL INVESTIGATION WAS PERFORMED ON THE DEVICE, CONFIRMING AN ISSUE. NO VISIBLE ANOMALIES WERE FOUND WITH THE EXTERIOR OF THE PUMP. FUNCTIONAL TESTING OF THE UNIT CONFIRMED THE ISSUE. ENGINEERING WAS UNABLE TO INQUIRE THE PUMP. THE PUMP COVER WAS REMOVED TO OBSERVE THE INTERNAL COMPONENTS. IT WAS OBSERVED THAT THE INTERNAL ELECTRONICS CAVITY SHOWED SIGNS OF CORROSION AND DAMAGE DUE TO MOISTURE. ENGINEERING CONFIRMED A LEAK FROM THE VALVE TO THE BASEPLATE WELD. THIS LEAK IS THE CAUSE FOR THE ISSUE. THIS ISSUE WAS REVIEWED AND THE OPERATOR WAS RETRAINED IN THE PROCESS 0092-00913. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE AN IMPROPER WELD OF THE INLET VALVE TO THE BASEPLATE, LEADING TO A LEAK OF FLUID INTO THE COMPONENT CAVITY. INTERNAL COMPLAINT NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    PENDING COMPLETION OF DEVICE ANALYSIS AND REVIEW OF DEVICE HISTORY RECORD AND WELL AS FOLLOW-UP ON DETAILS. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    SENIOR QUALITY TECHNICIAN CONTACTED TECHNICAL SOLUTIONS TO REPORT A PROMETRA II PUMP THAT WAS EXPLANTED. NOTES FROM CLINICAL SPECIALIST (CS) INDICATE THAT THE PUMP WAS EXPLANTED DUE TO TWO LARGE VOLUME DISCREPANCIES. THE PATIENT ALSO ALLEGED AN INCREASE IN PAIN. CS STATED THAT A CAP STUDY WAS PERFORMED AND THAT THE CATHETER WAS DETERMINED TO BE PATENT. IT WAS ALSO STATED THAT FLOWONIX REFILL KITS ARE NOT USED DURING REFILL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88351 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 13827 25725 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention