BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG6301 DUAL CHNL VOL INFUSION PUMP

    MDR report key: 1231343 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88276
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    May 1, 2007
    Report Date
    May 16, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF THE OVERINFUSION WAS NOT DUPLICATED OR CONFIRMED. THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTS PRIOR TO CUSTOMER RETURN.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 FACILITY REPRESENTATIVE REPORTED THAT THE PUMP WAS INFUSING TOO QUICKLY. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PATIENT INFUSION. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF INJURY OR MEDICAL INTERVENTION. 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