BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 2051280 · Received April 12, 2011

    Report

    Report Number
    6000001-2011-02788
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF THE COLLEAGUE INFUSION PUMP WITH A LOW BATTERY ALARM WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS DEFECTIVE MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO CORRECT THE PROBLEM. ADDITIONAL: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. (B)(4). BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY EVENTS AND FOLLOW EXISTING ESCALATION PROCESSES TO ASSESS THE IMPACT ON PATIENT SAFETY.

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN REPORTED FINDING A FLO-GARD INFUSION PUMP WITH A LOW BATTERY ALARM OCCURRING DURING THE BATTERY OPERATION TEST. THIS ALARM INTERRUPTED DELIVERY. THIS EVENT OCCURRED DURING PRODUCT EVALUATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1