BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1874481 · Received October 19, 2010

    Report

    Report Number
    6000001-2010-04267
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 2 WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY THE PUMP'S DOOR ASSEMBLY BEING CRACKED AT THE LOWER HINGE STOP. THE DOOR ASSEMBLY WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WITH FAILURE CODE 2, WHICH IS A DOWNSTREAM OCCLUSION FAILURE CODE. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THE FACILITY REPRESENTATIVE DID NOT HAVE INFORMATION REGARDING WHETHER THERE HAVE BEEN ANY REPORTS OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THIS FACILITY WAS NOT WILLING TO BE CONTACTED FOR ANY FURTHER INFORMATION. DURING PRODUCT EVALUATION, FAILURE CODE 2 WAS CONFIRMED TO BE CAUSED BY THE DOOR ASSEMBLY BEING CRACKED AT THE LOWER HINGE STOP, INDICATING FAILURE CODE 2 WAS A FALSE OCCLUSION ALARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1