BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1212348 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88969
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 27, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 25, 2007. THE PUMP HAS NOT YET BEEN RECEIVED FOR EVALUATION. WHEN THE PUMP IS RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED OVERINFUSION DURING PATIENT USE. THE PUMP WAS PROGRAMMED TO ADMINISTER 250 MG OF LEVEQUIN. PUMP ACTUALLY INFUSED 500MG AS A SECONDARY MEDICATION. PUMP ALARMED AND WENT TO THE PRIMARY MEDICATION OF SALINE. PUMP WAS REPLACED. NO ADDITIONAL THERAPY WAS ADMINISTERED TO THE PATIENT AS A RESULT OF THIS OVERINFUSION. ADDITIONAL CONTACT INFORMATION IS AVAILABLE. 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 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE (SG) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1