BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3173094 · Received May 30, 2013

    Report

    Report Number
    1314492-2013-00668
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 26, 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
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS NOT RECEIVED OR EVALUATED BY BAXTER. IF THE DEVICE IS RETURNED TO BAXTER, AN EVALUATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP UNDER INFUSED TYLENOL TO A PATIENT (INFUSION PARAMETERS UNKNOWN). THIS EVENT OCCURRED IN THE OB DEPARTMENT. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239254 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1