BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1030823 · Received April 17, 2008

    Report

    Report Number
    6000001-2008-00250
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A BAXTER SVC TECH EVALUATED THE PUMP. THE REPORTED CONDITION OF "OCCLUSION WITH NO ALARM" WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO LARGO CUSTOMER SVC A PUMP WITH AN OCCLUSION WITH NO ALARM. THIS EVENT OCCURRED DURING PT USE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSP REP. NO ADD'L INFO IS AVAILABLE. DURING SVC THE REPORTED CONDITION WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1