BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1230148 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88799
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 18, 2007
    Report Date
    June 18, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPRESENTATIVE REPORTED AN OCCLUSION ALARM. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PATIENT INFUSION. EVALUATION SUMMARY: THE PUMP WAS EVALUATED ON-SITE BY A BAXTER SERVICE TECHNICIAN. INSPECTION OF THE DEVICE FOUND THAT THE OCCLUSION ALARM WAS CAUSED BY CRACKED UPPER AND LOWER DOOR HINGES. THE DOOR ASSEMBLY WAS REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, CRACKED UPPER AND LOWER DOOR HINGES WERE 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 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1