BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    MDR report key: 1240625 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04285
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 15, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A BAXTER SERVICE TECHNICIAN EVALUATED THE DEVICE ON-SITE AND FOUND CRACKED DOOR HINGES ON CHANNEL 2. THE REPORTED CONDITION OF THE CRACKED DOOR WAS CONFIRMED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A CRACKED DOOR. 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 FLO-GARD 6301 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1