BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 5719967 · Received June 13, 2016

    Report

    Report Number
    1314492-2016-03518
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    April 1, 2016
    Report Date
    May 19, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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

    MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. DURING EVALUATION IT WAS IDENTIFIED THAT THE MECHANISM SUB ASSEMBLY AND ULTRASONIC SENSOR ASSEMBLY INSTALLED IN DEVICE SERIAL NUMBER 933467 WERE NOT ORIGINALLY INSTALLED INTO THIS PUMP. THE INSTALLED MECHANISM SUB ASSEMBLY AND ULTRASONIC SENSOR ASSEMBLY BELONG TO A DIFFERENT UNKNOWN DEVICE. REVIEW OF THE SERVICE HISTORY RECORD AND DEVICE HISTORY RECORD REVEALED THAT THE COMPONENTS SHOULD BE: MECHANISM SUB ASSEMBLY (20120207-146) AND ULTRASONIC SENSOR ASSEMBLY (12038-83). THIS IS AN INDICATION THAT THE MECHANISM SUB ASSEMBLY AND ULTRASONIC SENSOR ASSEMBLY WERE NOT ORIGINAL TO THE DEVICE AND WERE INSTALLED OUTSIDE THE FACTORY, AN OPERATION THAT IS NOT PERMITTED. THIS UNAUTHORIZED REPAIR PERFORMED OUTSIDE THE FACTORY EXPOSED THE INTERNAL ESD SENSITIVE COMPONENTS, COMPROMISING ALL INTERNAL ELECTRICAL COMPONENTS RENDERING THE UNIT IRREPARABLE. IN THE WARNINGS AND CAUTIONS OF THE SPECTRUM OPERATORS MANUAL, IT STATES "SERVICING THE SIGMA SPECTRUM INFUSION SYSTEM IS RESTRICTED TO QUALIFIED, SIGMA TRAINED, SERVICE PERSONNEL WHO EMPLOY SIGMA AUTHORIZED PARTS AND PROCEDURES. USE OF OTHER PARTS AND SERVICING PROCEDURES IS PROHIBITED. THE DEVICE COULD NOT BE REPAIRED AND HAS BEEN REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    DURING BAXTER'S EVALUATION OF A SPECTRUM PUMP, EVIDENCE OF TAMPERING/UNAUTHORIZED SERVICE WAS FOUND. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT WITH THE DEVICE AFTER THE UNAUTHORIZED SERVICE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375717 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1