BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3173104 · Received May 30, 2013

    Report

    Report Number
    1314492-2013-00672
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER 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 PATIENT OPENED THE PUMP DOOR, REMOVED THE IV SET AND UNCLAMPED THE LINE, WHICH RESULTED IN AN UNCONTROLLED FLOW. THE CUSTOMER STATED THAT THE KEYPAD WAS LOCKED BUT THE PATIENT WAS ABLE TO OPEN THE DOOR BY INSERTING THE SLIDE CLAMP. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY. THE CUSTOMER STATED THAT THE DEVICE CAN NOT BE IDENTIFIED AND WILL NOT BE RETURNED TO BAXTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238718 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1