BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3181745 · Received June 6, 2013

    Report

    Report Number
    1314492-2013-00712
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVALUATION CONFIRMED THAT THROUGH A DEVICE HISTORY LOG REVIEW, THE REPORTED PROGRAMMED INFUSION PARAMETERS ON THE REPORTED DAY OF THE EVENT. THE HISTORY LOG SHOWS THAT THE INFUSION WAS NEVER FULLY COMPLETED. EVALUATION COULD NOT CONFIRM OR REPRODUCE THE REPORTED SYMPTOM. THE DEVICE PASSED FLOW RATE TESTING PER THE PREVENTATIVE MAINTENANCE PROCEDURE, AS WELL AS ADDITIONAL FLOW RATE TESTING. THE DEVICE PASSED UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTING PER THE PREVENTATIVE MAINTENANCE PROCEDURE, AS WELL AS ADDITIONAL OCCLUSION TESTING. THE DEVICE WAS DETERMINED TO OPERATE WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP UNDER INFUSED LEUCOVORIN TO A PATIENT IN THE HEMATOLOGY / ONCOLOGY CARE AREA. IT WAS REPORTED THE PROGRAMMED INFUSION PARAMETERS WERE 123.163 ML IN TWO HOURS. THE CUSTOMER HAD STATED THAT ONLY 2.4 ML OF LEUCOVORIN WERE INFUSED OVER A TWO HOUR PERIOD. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251951 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 DEHP BAXTER PRIMARY IV SETS| PHASEAL CONNECTOR| CADD AMBULATORY PUMP