BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1905058 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05140
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    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 IN SERVICE. THE ASSIGNABLE CAUSE WAS A DEFECTIVE MOTOR. THE MOTOR HAS BEEN REPLACED. ADDITIONAL: A SERVICE HISTORY REVIEW HAS BEEN PERFORMED. THE DEVICE HAS NOT BEEN SERVICED PREVIOUSLY FOR THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A INFUSOR PUMP WITH A CONDITION OF "PUMP WAS DROPPED BOLUS KNOB STICKS". THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. DURING THE PRODUCT EVALUATION AT BAXTER IT WAS DISCOVERED THAT A CONSTANT ALARM WAS RECEIVED AFTER THE PUMP STARTED TO RUN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6461500 INFUSOR PUMP (1 LABEL) PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1