BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION PUMP

    MDR report key: 9727694 · Received February 19, 2020

    Report

    Report Number
    3012307300-2020-01188
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Report Date
    July 11, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECIEVED THAT THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 0

    THE PUMP ASSOCIATED WITH THIS COMPLAINT WAS INADVERTENTLY RETURNED TO THE CUSTOMER WITHOUT AN INVESTIGATION BEING PERFORMED. CORRECTIONS TO THE S&R PROCESS HAVE BEEN IMPLEMENTED TO PRECLUDE THIS TYPE OF ERROR FROM OCCURRING. ORACLE NOTES: "UPON POWERING UP DEVICE, SW IS CONFIRMED TO BE V3.0.6 DUE TO EOL OF THIS SW, WILL NOT BE ABLE TO PERFORM SERVICE/REPAIR. WILL SEND DEVICE BACK TO CUSTOMER UNREPAIRED AND INCLUDE EOL LETTER. STICKER AFFIXED TO DEVICE " THIS DEVICE HAS NOT BEEN REPAIRED AND DOES NOT MEET MANUFACTURE'S SPECIFICATION. DO NOT RETURN THIS DEVICE TO CLINICAL USE". KA D A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. UPDATED B 1, B 4, B 5, D 10, G7, H 1, H 2, H 3, H 6 AND H 10.

    Description of Event or Problem · 0

    CORRECTIVE INFORMATION IN H 10.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION PUMP HAD AUDIBLE ALARM FAILURE. IT WAS NOT SPECIFIED WHETHER THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191094 MEDFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 3500

    Patients

    Seq Age Sex Outcome Treatment
    1