BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2992448 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05477
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 18, 2013
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER'S REPORTED PROBLEM OF A FLOGARD INFUSION PUMP THAT "DOES NOT INFUSE" WAS CONFIRMED ON CUSTOMER SITE BY SERVICE AS F-73, WHICH IS A PUMP MOTOR-RELATED FAILURE. SERVICE DETERMINED THAT THE CAUSE WAS DUE TO LOOSE MOTOR COUPLINGS, WHICH WERE TIGHTENED ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT "DOES NOT INFUSE". IT IS UNKNOWN IF THIS EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97108 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1