BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 2042568 · Received April 6, 2011

    Report

    Report Number
    6000001-2011-02612
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    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). 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). EVALUATION SUMMARY: THE FOUND CONDITION OF A FLOGARD INFUSION PUMP THAT EXPERIENCED AN AIR-IN-LINE ALARM AT THE START OF DELIVERY WAS CONFIRMED IN SERVICE. THE CAUSE OF THE MALFUNCTION WAS FOUND TO BE A FAULTY AIR SENSOR ON THE PRINTED CIRCUIT BOARD. THE AIR SENSOR WAS REPLACED TO FIX THE REPORTED CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER DISCONTINUED SERVICE AND CEASED ALL DESIGN RELATED SUPPORT ON FLO-GARD (B)(4) IN THE U.S. REGION AS OF (B)(6) 2010. 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.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND WITH A FALSE AIR IN LINE ALARM AT THE START OF DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. 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