BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2202728 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18305
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'?S REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A BROKEN POWER CORD WAS NOT CONFIRMED OR DUPLICATED DURING PRODUCT EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED FOR THIS CONDITION AND NO REPAIR WAS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERVICE HISTORY REVIEW REVEALED THAT THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF A BROKEN POWER CORD. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A FLO-GARD INFUSION PUMP WITH A BROKEN ALTERNATE CURRENT POWER CORD, WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. IT WAS NOT SPECIFIED IF THERE WAS PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1