BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 2001919 · Received February 27, 2011

    Report

    Report Number
    6000001-2011-01360
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE DEVICE WITH THIS SERIAL NUMBER. (B)(4). BAXTER WILL CONTINUE TO COLLECT PRODUCT COMPLAINTS, BUT PERIODIC MONITORING/TRENDING AND ANALYSES OF THE U.S. COMPLAINTS FOR PRODUCT IMPROVEMENTS WILL NO LONGER BE REQUIRED. BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY EVENTS AND FOLLOW EXISTING ESCALATION PROCESSES TO ASSESS THE IMPACT ON PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    FLO-GARD DEVICES ARE NO LONGER BEING SERVICED BY BAXTER, THEREFORE THE DEVICE WILL NOT BE RETURNED FOR REPAIRS/EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLO-GARD INFUSION PUMP THAT OVER-INFUSED (DELIVERED TOO QUICKLY) DURING DELIVERY OF SALINE TO A PATIENT. THE FACILITY REPRESENTATIVE DID NOT INDICATE THE PERCENTAGE OF OVER-INFUSION. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. 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 SALINE