BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL MEDFUSION 4000 PUMP

    MDR report key: 10077721 · Received May 21, 2020

    Report

    Report Number
    3012307300-2020-04670
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Report Date
    May 20, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586043567
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RETURNED DEVICE WAS RECEIVED WITH BOTTOM CASE CRACKED BY L-BRACKET, RIPPED PLUNGER TUBE SEAL. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED. NO FAULT FOUND. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE & REPAIR RECORDS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION 4000 PUMP,HADLOGIC BOARD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542932 SMITHS MEDICAL MEDFUSION 4000 PUMP PUMP, INFUSION, PRODUCT CODE: FRN FRN SMITHS MEDICAL ASD, INC. 4000 10610586043567

    Patients

    Seq Age Sex Outcome Treatment
    1