BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 2041861 · Received April 6, 2011

    Report

    Report Number
    6000001-2011-02600
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 12, 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). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS DEFECTIVE MAIN BATTERIES. THE MAIN BATTERIES HAVE BEEN REPLACED. ADDITIONAL: A SERVICE HISTORY REVIEW REVEALED THAT THE DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR 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 CONTINUES TO SUPPORT THE PRODUCT IN THE LATIN AMERICA REGION AND WILL DO SO UNTIL PARTS REMAIN AVAILABLE. BAXTER WILL CONTINUE TO COLLECT PRODUCT COMPLAINTS BUT PERIODIC MONITORING/TRENDING AND ANALYSES OF THE U.S. COMPLAINTS WILL NO LONGER BE REQUIRED. HOWEVER, BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY (DSI) EVENTS TO ASSESS THE IMPACT ON PATIENT SAFETY.

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN REPORTED FINDING A FLO-GARD INFUSION PUMP THAT FAILED THE BATTERY OPERATION TEST (STEP 9.15). THIS EVENT OCCURRED DURING PRODUCT EVALUATION AND MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. 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