BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3173105 · Received May 30, 2013

    Report

    Report Number
    1314492-2013-00673
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A FOLLOW UP PHONE CALL THE CUSTOMER STATED THAT THEY EVALUATED THE EVENT AND DETERMINED THAT THE OVER INFUSION WAS THE RESULT OF THE USER PROGRAMMING THE PUMP FOR AN UNINTENDED RATE. THE CUSTOMER STATED THEY DO NOT ALLEGE A DEVICE MALFUNCTION. 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 OF CYTARABINE A PUMP OVER INFUSED. THE CUSTOMER STATED THAT THE INTENDED DURATION OF THE INFUSION WAS 24 HOURS AND THE INFUSION WAS COMPLETED IN 16 HOURS. THE CUSTOMER STATED THAT THIS INFUSION WAS A PART OF A 5 DAY INFUSION REGIMEN INVOLVING MULTIPLE PUMPS AND THAT FOLLOWING THE HOSPITALS INTERNAL REVIEW OF THE EVENT THE OVER INFUSION WAS ATTRIBUTED TO A USER ERROR WHILE PROGRAMMING THE PUMP RESULTING IN THE UNINTENDED INFUSION RATE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239837 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1