BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6857268 · Received September 12, 2017

    Report

    Report Number
    1314492-2017-01729
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Report Date
    October 6, 2017
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    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

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BAXTER RECEIVED AND EVALUATED THE DEVICE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED OVER INFUSION WHICH WAS REPRODUCED. THE MECHANISM CURRENTLY INSTALLED BELONGS TO PUMP SERIAL NUMBER 987857 AND IS OWNED BY THE SAME CUSTOMER AS THE DEVICE IN QUESTION, SERIAL NUMBER 923811. THEREFORE, ENGINEERING INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE OVER INFUSION IS UNDER-TRAVELED FINGERS AND VALVES DUE TO AN UNAUTHORIZED USER FACILITY REPAIR. THE DEVICE WILL NOT BE SERVICED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP OVER INFUSED DURING THERAPY IN THE MEDICAL/SURGICAL DEPARTMENT (DOSE, MEDICATION, VOLUME, AND RATE UNKNOWN). THERE WAS NO INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637308 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1