BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063,

    MDR report key: 1873213 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04202
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW REVEALED THIS DEVICE HAS BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A FLO-GARD INFUSION PUMP WHICH FAILED TO ALARM FOR AIR IN THE LINE WAS FOUND AND CONFIRMED BY A BAXTER SERVICE TECHNICIAN. THIS CONDITION WAS CAUSED BY A FAULTY AIR SENSOR. THE AIR SENSOR WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP FAILED TO ALARM FOR AIR IN THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063, PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1