BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD

    MDR report key: 2121065 · Received June 13, 2011

    Report

    Report Number
    6000001-2011-07568
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 20, 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). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH FAILURE CODE 38 WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY A MALFUNCTION IN THE TUBE MISLOADING DETECTION CIRCUITRY AND BY BAD CONTACT IN THE TUBE MISLOAD DETECTOR HARNESS. THE TUBE MISLOAD SENSORS AND TUBE MISLOAD DETECTOR HARNESS WERE REPLACED TO CORRECT THE REPORTED CONDITION. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. 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 FOR PRODUCT IMPROVEMENTS 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

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WITH FAILURE 38. THIS EVENT OCCURRED IN THE SURGERY DEPARTMENT AND MAY HAVE INTERRUPTED 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 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1