BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1840452 · Received September 21, 2010

    Report

    Report Number
    6000001-2010-03400
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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 IN THE PUMP'S ALARM LOG BUT NOT DUPLICATED DURING PRODUCT EVALUATION. HOWEVER, THE CHANNEL 1 AND 2 DOOR LATCH ROLLERS WERE FOUND TO BE WORN, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE CODE 2. THE CHANNEL 1 AND 2 DOOR LATCH ROLLERS WERE REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM WITH THIS PUMP. THIS MDR WAS SUBMITTED ON (B)(4) 2010; HOWEVER, DUE TO A FAILURE TO RECEIVE ACK3, THIS MDR IS BEING RESUBMITTED ON (B)(4) 2010.

    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. THIS FACILITY WAS NOT WILLING TO BE CONTACTED FOR ANY FURTHER INFORMATION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. DURING PRODUCT EVALUATION, THE CHANNEL 1 AND 2 DOOR LATCH ROLLERS WERE FOUND TO BE WORN, 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 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1