BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3031380 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08132
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF F38 ALARM WAS CONFIRMED BY THE SAMPLE EVALUATION. THE CAUSE WAS IDENTIFIED TO BE THAT THE LEFT FSR WAS DAMAGED. TO RESOLVE THE REPORTED CONDITION, THE LEFT FSR WAS REPLACED. NO FURTHER ACTION REQUIRED AS THE DEVICE PASSED ALL TESTS PERFORMED PER BAXTER PROCEDURES. THE DEVICE WAS RETURNED TO THE CUSTOMER IN GOOD WORKING CONDITION. THE CAUSE OF THE REPORTED PROBLEM WAS IDENTIFIED TO BE THAT THE LEFT ROLLER WAS DAMAGED. TO RESOLVE THE REPORTED PROBLEM, THE LEFT ROLLER WAS REPLACED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED CONDITION OF F38 ALARM WAS CONFIRMED BY THE SAMPLE EVALUATION. THE CAUSE WAS IDENTIFIED TO BE THAT THE LEFT FSR WAS DAMAGED. TO RESOLVE THE REPORTED CONDITION, THE LEFT FSR WAS REPLACED. NO FURTHER ACTION REQUIRED AS THE DEVICE PASSED ALL TESTS PERFORMED PER BAXTER PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD PUMP ALARMED WITH CODE F38. NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION WAS REPORTED WHEN THIS EVENT WAS RECEIVED. ADDITIONAL INFORMATION IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133580 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1