BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2990113 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05278
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM OF " BATTERY LOW ALARM" WAS CONFIRMED VIA VISUAL INSPECTION DURING THE SAMPLE EVALUATION. THE CAUSE OF THE PROBLEM WAS A DAMAGED BATTERY (ACID DAMAGE TO THE BATTERY LEAD). SERVICE REPLACED THE BATTERY TO FIX THE PROBLEM. DEVICE PASSED ALL FURTHER TESTING. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON-SITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOW BATTERY ALARM OCCURRED WITH A FLOGARD INFUSION PUMP. 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
    93493 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1