BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2547146 · Received April 24, 2012

    Report

    Report Number
    6000001-2012-08707
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    September 26, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CONDITION OF AN INFUSO.R. WITH A "OBF-PUMP WILL NOT WORK WHEN YOU TRY TO TURN IT ON" ISSUE WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE AN OUT-OF-BOX FAILURE DUE TO INCORRECT BATTERIES. THE BATTERIES WERE REPLACED WITH A DIFFERENT BRAND OF C BATTERIES IN ORDER TO RESOLVE THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSO.R. WITH "OBF-PUMP WILL NOT WORK WHEN YOU TRY TO TURN IT ON". THIS EVENT OCCURRED UPON POWER UP IN BIOMED SERVICE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1