BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG6301 DUAL CHNL VOL INFUSION PUMP

    MDR report key: 1231387 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88275
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 8, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPRESENTATIVE REPORTED AN UNSPECIFIED ALARM SITUATION FOUND BEFORE USE.EVALUATION SUMMARY: THE PUMP WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN. INSPECTION OF THE DEVICE FOUND A CONSTANT DOWNSTREAM OCCLUSION ALARM CAUSED BY A CRACKED DOOR ASSEMBLY ON CHANNEL 1. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN REVIEWED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, A CRACKED DOOR ASSEMBLY ON CHANNEL 1 WAS FOUND. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG6301 DUAL CHNL VOL INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1