BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2946199 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03070
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    August 31, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED PROBLEM WAS CONFIRMED BY BAXTER QUALITY ENGINEERING AS MOTOR ISSUE. THE CAUSE OF THE PROBLEM WAS THE MOTOR BEING DISENGAGED FROM THE GEAR BOX AND THE RED BATTERY WIRE BEING BROKEN. NO REPAIRS WERE MADE AS THE PUMP WAS SENT FOR DESTRUCTION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSOR PUMP WITH A CONDITION OF "PUMP IS NOT WORKING AT ALL. CUSTOMER WOULD LIKE AN "OVERHAUL" ON MACHINE". IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. HOWEVER, IT IS KNOWN TO HAVE OCCURRED IN THE "OUTPATIENT SURGERY" DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT/USER INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE FACILITY REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51268 INFUSO.R. PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1