BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2223375 · Received August 25, 2011

    Report

    Report Number
    6000001-2011-20643
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A BROKEN DOOR LATCH WAS CONFIRMED AND DUPLICATED BY BAXTER SERVICE PERSONNEL. THE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE A BROKEN DOOR LATCH. THE DEVICE WAS RETURNED UNREPAIRED TO THE CUSTOMER. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLO-GARD INFUSION PUMP WITH A BROKEN DOOR LATCH. IT IS UNKNOWN WHEN, OR IN WHICH CARE AREA, THIS EVENT OCCURRED. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT 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