BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 PUMP CARRIER

    MDR report key: 2904401 · Received November 30, 2012

    Report

    Report Number
    1314492-2012-00474
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO SIGMA FOR EVALUATION AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFUSION, THE SCREWS CAME OUT OF THE THREE PUMP CARRIER THAT THE PUMP WAS LOCATED ON. THE CUSTOMER STATED THAT WIRES TOUCHED CREATING A SPARK AND BLACK SMOKE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 PUMP CARRIER PUMP CARRIER FRN BAXTER HEALTHCARE CORP. 55093

    Patients

    Seq Age Sex Outcome Treatment
    1