BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3240896 · Received July 17, 2013

    Report

    Report Number
    1314492-2013-01348
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP CORD GROUND PRONG STUCK OUT OF AN OUTLET IN A PT ROOM. A HOSPITAL EMPLOYEE WAS SHOCKED WHEN THE EMPLOYEE BRUSHED BY THE OUTLET AND MADE CONTACT WITH THE GROUND PRONG. THE EMPLOYEE EXPERIENCED TINGLING. NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332004 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other