BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    MDR report key: 1024060 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-04390
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 29, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON FEB 14 2007. EVALUATION SUMMARY:REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THE ISSUE IS BEING INVESTIGATED UNDER CAPA #MDQ-CAPA.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED, BROKEN DOOR DURING BIO-MED TESTING. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITONAL CONTACT INFORMATION. ACCORDING TO THE FACILITY REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS 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