BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4843971 · Received June 5, 2015

    Report

    Report Number
    1314492-2015-06599
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    April 1, 2015
    Report Date
    May 8, 2015
    Manufacturer
    BAXTER HLTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED THE DEVICE IN QUESTION. THE CUSTOMER REPORT OF THE OVER INFUSION WAS RECEIVED BY BAXTER AFTER THE DEVICE WAS RECEIVED AND EVALUATED FOR A DIFFERENT SYMPTOM. THEREFORE, THE STATE OF THE DEVICE DID NOT ALLOW FOR FLOW RATE ACCURACY TESTING TO CONFIRM THE CUSTOMER ALLEGATION. THE DEVICE DID PASS FLOW RATE TESTING DURING THE INCOMING FUNCTIONALITY TESTING. ADDITIONALLY, THE DEVICE WAS FOUND TO BE IN SPECIFICATION IN REGARDS TO THE REPORTED OVER INFUSION, AND NO RELATED MALFUNCTION COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP OVER INFUSED. THE DEVICE WAS TESTED SEVERAL TIMES WITH "VARYING RESULTS" (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365728 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HLTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1