BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1030830 · Received April 17, 2008

    Report

    Report Number
    6000001-2008-00247
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 14, 2008
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A BAXTER SVC TECH EVALUATED THE PUMP. THE REPORTED CONDITION OF CONSTANT OCCLUSION ALARMS ON BOTH PUMPS 1 AND 2 WAS CONFIRMED. DOOR SHIMS WERE ADDED TO PUMP 1 AND PUMP 2 DOOR ASSEMBLIES TO FIX THE ASSIGNABLE CAUSE. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED "BOTH SIDES BEEP OCCLUSION CONSTANTLY" ON A FLOGARD PUMP DURING PT INFUSION. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFO, DETAILS WERE NOT AVAILABLE REGARDING ADD'L CONTACT INFO. ACCORDING TO THE FACILITY REP, NO PT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED RELATED TO THE DEVICE. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE 80FRN FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1