BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1950014 · Received January 6, 2011

    Report

    Report Number
    6000001-2011-00083
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CONDITION OF A FLOGARD INFUSION PUMP WITH AN OCCLUSION ALARM ON CHANNEL B WAS FOUND AND CONFIRMED BY A BAXTER SERVICE TECHNICIAN. AN ASSIGNABLE CAUSE WAS NOT DETERMINED FOR THIS CONDITION. DUE TO CUSTOMER DENIAL OF THE COST OF REPAIR ESTIMATE, NO REPAIRS WERE MADE TO THIS PUMP AND IT WAS RETURNED UN-REPAIRED TO THE CUSTOMER. SERVICE HISTORY REVIEW: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. CAPA ASSESSMENT: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP THAT DISPLAYED AN OCCLUSION ALARM, WHICH OCCURRED DURING PROGRAMMING/SET-UP IN THE EMERGENCY ROOM. THIS EVENT MAY HAVE BEEN A FALSE OCCLUSION ALARM. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1