BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 10868833 · Received November 19, 2020

    Report

    Report Number
    3012307300-2020-11594
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Report Date
    November 19, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586040818
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MEDFUSION PUMP WAS RECEIVED WITH THE TOP AND BOTTOM CASES IN EXCELLENT CONDITION AND NO VISIBLE CONTAMINATION. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A POSITIVE SUPPLY BACKGROUND TEST MESSAGE. THE POWER UP PROCESS WAS CONDUCTED AND THE BIOMED DIAGNOSTICS MONITOR WAS ALSO USED. THE REPORTED ISSUE WAS ABLE TO BE DUPLICATED DURING THE POWER UP PROCESS. THE MAIN PRINTED CIRCUIT BOARD (PCB) NO LONGER OPERATED PROPERLY AS A RESULT OF NORMAL WEAR. THE PUMP IS OVER 8 YEARS OLD. 6811 A2D GRP 1 VOLTAGE ON THE MAIN BOARD. THE POWER SUPPLY IS BELOW THE SPECIFIED TOLERANCE. THE VOLTAGE READING= 7.958 VOLTS. IT SHOULD BE 9.472 +/- 5%. THE MAN PCB WILL BE REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION PUMP GAVE A BIOMED CODE, WAS TROUBLESHOOTED, THEN TURNED ON WITH A BLANK SCREEN AND ALARMS. THERE WAS NO REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332283 MEDFUSION PUMP, INFUSION FRN ST PAUL 4000 10610586040818

    Patients

    Seq Age Sex Outcome Treatment
    1